International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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1. Development of Reverse Phase HPLC Method and Validation: Sofosbuvir and Velpatasvir Quantification in Bulk and Tablets
S Bhargavi, B Sailaja
A new reverse-phase high-performance liquid chromatography (RP-HPLC) method for measuring the amount of sofosbuvir and velpatasvir in active pharmaceutical ingredients (API) and tablet forms has been developed and the method was also validated. Discovery column C18 150 mm x 4.6 mm, pore size of 5 μm was used for the analysis of drugs. Elution of drugs was achieved with 0.1% OPA Buffer: Acetonitrile mixed in the proportion of 40:60 v/v was used as mobile phase, maintaining 1.0 mL/min as flow rate, column temperature maintained at 30°C and uv detector wavelength was fixed at 272 nm. Sofosbuvir and velpatasvir were eluted at retention time (RT) of 2.183 and 3.038 minutes, respectively. Linearity parameter was performed in the levels from 25 to 150% and the square of correlation coefficient (r2) was found to be 0.9992. The % recovery obtained for sofosbuvir was 99.6 and for velpatasvir was 99.4. In precision % RSD for sofosbuvir was found to be 0.4 and for velpatasvir was 0.9. Validation was performed for the developed method and all of the validated parameter results obtained was within the ICH Q2 guidelines acceptance range. So, the developed RP-HPLC method can be used in pharmaceutical industry for quantification of sofosbuvir as well as velpatasvir at once in API and tablet dosage form.

2. Development and Evaluation of Eplerenone Microbeads as Floating Drug Delivery System using Design of Experiment
Rambabu Boorugu, Radha GV
The present study was designed to formulate floating microbeads of eplerenone for decreasing dosing frequency and increasing gastric residence. The floating properties of the gastric juice were used to control the stomach stay time. Eplerenone was selected as a model bioactive which is used in lowering blood pressure by loading into floating microspheres was designed by using polymer ethyl cellulose and solvent ratio (Dichloromethane: methanol), keeping. The floating microbeads were studied for their drug entrapment efficiency, shape, percentage yield, and particle size, surface morphology, in-vitro drug release studies, percentage buoyancy, and formulation stability studies. Dichloromethane we used (DCM) as a constant and stirred them for hours. The study showed that fluid evaporation can be used to make floating microbeads that contain eplerenone. This method can be used to successfully make eplerenone-loaded floating microbeads. The study showed that making floating eplerenone microbeads with controlled release is a good way to cut down on how often you have to take your medicine.

3. Pre-clinical Study of Marketed Polyherbal Formulations on Blood Glucose Level and Associated Parameters in Streptozotocin-induced Diabetes
Nikumbh K K, Patil R A, Upasani C D
The management of diabetes mellitus involves lowering blood glucose levels with anti-diabetic drugs. Globally and nationally, the demand for herbal goods is increasing correspondingly. There have been numerous polyherbal preparations with anti-diabetic activity discovered during the past few decades. For both their antidiabetes and potential to avert diabetic complications, two different commercial polyherbal preparations were tested. For the purpose of choosing a commercial polyherbal formulation, a survey was conducted. The formulations were chosen based on their similarity in terms of their constituents, their estimated efficacy, how frequently they were distributed, and their price range. STZ-induced diabetic rats were utilized as a model and metformin was the standard medication for evaluating the antidiabetic activity. Selected polyherbal formulations, including formulation A and formulation B, demonstrated effective anti-diabetic action. In comparison to diabetic control groups, polyherbal formulations meaningfully decreased glucose levels in diabetic rat’s blood and other diabetic complications metrics such as serum Serum glutamic oxaloacetic transaminase (SGOT), Serum glutamate pyruvate transaminase (SGPT), triglyceride, and cholesterol, as a marker for liver problems, and organ weight variation.

4. The Effect of Contraceptive Pills on the Physiological Parameters of Blood and Hormones on Women in Al-Qurna, Iraq
Mohammad J Al-Jassani, Saif Y Hasan, Ahmed Adnan, Omer QB Allela, Khulood M Alsaraf, Abed J Kadhim, Alzahraa S Abdulwahid
This study was conducted to find out the use of oral contraceptive pills and their effect on some physiological blood parameters (platelet count, red blood cell count, white blood cell count, hemoglobin rate, physiological blood parameters, and cholesterol). The results between 10 women of reproductive age who were not taking oral contraceptives, and 10 women of reproductive age who were taking oral contraceptives showed no significant differences among physiological blood parameters (p >0.05) but there were significant differences among estrogen and progesterone hormones in women who did not take birth control pills.

5. Development and Validation of Stability Indicating RP-HPLC Method and Characterization of Degradation Products of Anti-neoplastic Agent by LCMS-MS
K Anusha, G Sowjanya
In present research a stability indicating reversed-phase high-performance liquid chromatography (RP-HPLC) was developed and validated for quantification of azacitidine and its degradants. The chromatographic isolation of azacitidine carried out using Phenominex C18 (150×4.6 mm, 5 μ) column, movable phase of 0.1% HCOOH in water and acetonitrile (30:70 v/v), at a flowing rate of 1-mL/min analyzed at 210 nm. The %recovery findings ranged between of 99.13–99.41%. The limit of detection (LoD), and limit of quantitation (LoQ)values were assessed from the rectilinear plot and were found to be 3.78 and 15.12 μg/mL. The regression equation of the linearity curve was found to be y = 851.76x + 310.38 and r2 value of 0.9998. The samples were subjected to stress degradation and characterized by three acid degradation products by liquid chromatography-mass spectrometry (LC-MS/MS) – DPI, DPII, and DPIII. The stationary phase and movable system attained excellent resolution as chromatographic isolation and structure identification was accomplished using LC-MS/MS fragmentation.

6. Solubility and Taste Masked Behaviour of Cyclodextrin Molecular Inclusion Complex of Artemether
Rahul Bijwar, Harshal Tare
Artemether by forming a complex with β-cyclodextrine (βCD) is used to improve solubility and taste masked by the kneading method. Artemether with β-cyclodextrine complex prepared with βCD in a drug-polymer ratio 1:1 gave complete taste masking with the satisfactory result obtained in term of in-vivo and in-vitro evaluation. The standard calibration curve of Artemether shows a slope of 0.0154 and a correlation coefficient of 0.9992. Compatibility studies show that drugs are compatible with polymers. Solubility studies show that the solubility of drug are increased in Phosphate buffer 6.8 by successfully forming a complex with βCD. In-vitro dissolution results showed that a maximum of 97.05% of Artemether, drug release less than 15 minutes in formulation. The solubility of Artemether in saliva (PH 6.8) is 0.00735 mg/mL, After complex forming with β-cyclodextrin the solubility of (Artemether complex) is 0.124 mg/mL. In-vitro drug release investigation, taste masking occurs when the amount of drug substance in the dissolve medium is either not identified or is below the threshold for recognizing its flavor in the early time points (between 0 and 5 minutes). Taste masking ( Taste perception test) 11 volunteers were selected for this test, results show that complex is taste masked. Artemether with βCD complex is a hopeful method to augment the solubility, dissolution and taste masking of the drug.

7. Stability-Indicating Liquid Chromatography Method for Rifaximin and LC-MS Characterization of its Potential Degradants
Prashant Chaturvedi, Shruti Chopra, Pradnya Desai, Savita Tauro
Rifaximin (RFX) is a structural analog of rifampin that has been shown to be a gastrointestinal-selective antibiotic with broad-spectrum antibacterial properties, a pronounced safety profile, and limited drug interactions. Crohn’s disease, diarrhea, hepatic encephalopathy, irritable bowel syndrome, and traveler’s diarrhea caused by non-invasive diarrheagenic Escherichia coli, can all be treated with rifaximin. FDA has designated RFX as an orphan drug for the treatment of hepatic encephalopathy. There is a substantial need for analytical quality monitoring of Rifaximin to ensure the safety and efficacy of treatment. To generate degradants, forced degradation study of the drug was carried out in acid, alkali, oxidative, thermal, and photolytic stress conditions. The optimum separation of the drug, and its degradants was achieved on an Inertsil ODS-3V C18 column (250 X 4.6 mm X 5 μm) under gradient elution conditions using, 10 mM potassium dihydrogen orthophosphate (pH 5.0 ± 0.05) as mobile phase A, and acetonitrile as mobile phase B, at a flow rate of 1.0 mL/min. The run time was 41 minutes and the detection wavelength was 258 nm. The method was validated in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human use Guidelines. The drug was stable in neutral hydrolysis, photo and dry heat degradation conditions. The percentage degradation observed during acid, alkali hydrolysis and oxidative stress conditions were 70.46, 15.11 and 24.18, respectively. The degradants were investigated by LC-MS which indicated the presence of four (m/z 784.2, 744.5, 784.3, 753.8), three (m/z 744.5, 784.3, 753.8) and five (m/z 772.4, 838.4, 744.5, 753.8, and 801.9) degradants in acid, alkali and oxidative stress conditions, respectively. The structures of degradants were elucidated using Liquid chromatography–mass spectrometry (LC-MS) and Liquid chromatography tandem mass spectrometry (LC-MS/MS) analyses.

8. Stability Indicating UV Spectrophotometric Method for Loxoprofen Sodium: Method Development and Validation
Rupesh Kulkarni, Mahesh Palled
Loxoprofen sodium was analyzed using UV spectrophotometry, and the method was designed and validated in the present study in accordance with ICH Q2 recommendations. Loxoprofen sodium’s stress degradation behavior was investigated using a newly discovered technique. Analysis was carried out at 223 nm by using distilled water as solvent. Stress degradation of drug was studied at acidic, basic and oxidative conditions. With a correlation coefficient of 0.999, linearity was found between 5 and 25 μg/mL. Intraday and interday precision studies showed RSD values of < 2.0%, demonstrating the accuracy of the presented approach. Results obtained for LoD and LoQ are 0.012 and 0.037 μg/mL, respectively. For the ruggedness study, the absorbance value of six replicates was found to be 0.477 ± 0.004 with %RSD > 2.0% states that the developed method was found to be rugged. During the stress degradation study, it was observed that the drug is susceptible to basic and oxidative conditions with degradation of more than 10%.

9. Docking Techniques for Unravelling the Molecular Mechanisms of Specioside of Kigelia africana Fruits
Jubilee R, Komala M
In this study, the inhibitors of α-amylase and aldose reductase, the key of proteins in diabetes mellitus, were isolated as compound speciosides from the Kigelia africana fruit Benth. Speciosides were selected as ligands for the receptors of α-amylase and aldose reductase in the molecular docking studies used by PyRx (0.8) for the inhibition of α-amylase and aldose reductase. The results showed that the α-amylase binding energy was 8.1 kcal/mol and aldose reductase was -9 kcal/mol. The ADME process showed that it was easily absorbed orally and distributed through the CNS, metabolized by CYP2D6, and excreted through renal Toxicity studies of speciosides showed no hepatotoxicity or skin sensitization. The in-silico studies of specioside compounds led to the development of potent α-amylase and aldose reductase inhibitors used to treat diabetic mellitus.

10. Ranolazine Quantification in Human Plasma: A QbD-Guided LC-MS Method Development and Validation
Jagirdar SZ Farooq, Furquan N Khan
The present research outlines a comprehensive and systematic approach for the development and validation of a bioanalytical LC-MS method to quantify ranolazine in human plasma. The study employs principles of quality by design (QbD) to enhance method robustness, precision, and accuracy. The primary goals of this research were to create a reliable LC-MS method for the accurate quantification of ranolazine in human plasma and to validate this approach in accordance with established standards set by regulatory bodies. A secondary objective was to explore the application of QbD principles to optimize method performance. The study resulted in the successful development of an LC-MS method that exhibits exceptional specificity, sensitivity, accuracy, and precision in the quantification of ranolazine in human plasma. Specificity tests revealed no interference from endogenous plasma components. The method demonstrated good sensitivity with LoQ of 5 ng/mL and LoD of 2 ng/mL. Accuracy, as assessed through recovery studies, showed mean recoveries of 98, 99, and 101% for three different spiked concentrations. Precision, expressed as RSD, was below 5% for both intra-day and inter-day analyses. Linearity studies resulted in a calibration curve with an R² value of 0.9998. By employing QbD principles, the method demonstrated improved robustness, thus minimizing the impact of variability during sample analysis. Robustness experiments revealed minimal effects on precision and accuracy when varying critical parameters. This research not only presents a reliable LC-MS method for ranolazine quantification but also underscores the importance of incorporating QbD principles in bioanalytical method development. The validated method holds significant implications for clinical research, pharmacokinetic studies, and therapeutic drug monitoring. By enhancing the accuracy and robustness of ranolazine quantification, this method contributes to the advancement of pharmaceutical and clinical research, ultimately benefiting patient care and treatment outcomes.

11. Isolation of Ethyl Acetate Fraction of Methanolic Extract of Cinnamomum malabatrum Leaves by Column Chromatography
Duguta Tirumala, V Jayashree
Cinnamomum malabatrum (Lauraceae) is available in the Western Ghats and south India, the leaves were collected shade dried and made into fine powder form, and the powder was subjected to extraction by different solvents like petroleum ether, methanol, and water. Further, these extracts were subjected to thin layer chromatography.
C. malabatrum ethyl acetate fraction of methanolic extract was given strong evidence for active components, based on evidence ethyl acetate fraction was subjected for further chromatographic separation; column chromatography was used for isolation of component of C. malabatrum ethyl acetate fraction of methanolic extract was subjected to column chromatography by using different ratios of mobile phases (in Hexane and Methanol). Flavonoids and phenols found present.

12. Method Development and Validation of Indigenously Isolated Caspofungin Acetate and its related Substances using RP-HPLC Method
Kiran K Gannamani, Sudhakar Chintakula, Suresh Maddila
Caspofungin is prepared from a precursor PneumocandinB0 derived from a fungus Glarea lozoyensis. Prepared crude Caspofungin Acetate has many impurities, namely, A, B, D, E and PneumocandinB0, and these impurities vary slightly in chemical or structural composition and need to be eliminated by purification. The present study involves the preparation of caspofungin acetate from PneumocandinB0, followed by purification and method development for detecting caspofungin and its related substances.” We used a high-tech liquid chromatograph system, which included components like the Agilent 1260 infinity quaternary pump module, a sophisticated MWD detector, and the Empower 3 data handling system. To separate and analyze substances, we employed an analytical column made of stainless steel. This column was 150 mm long and had an internal diameter of 3.0 mm. It was filled with octadecyl silane chemically bonded to porous silica particles, each with a tiny diameter of 3 micrometers. The test method underwent validation to ensure it could accurately identify specific elements, detect minimal quantities, establish the lowest measurable amounts, maintain linearity, demonstrate precision, achieve accuracy, and suitably handle sample solutions and the system.” and the developed test method is suitable and can be introduced into the routine use for the detection of caspofungin acetate and its related substances.

13. RP-HPLC Method Validation for Levomilnacipran Estimation in Bulk and Formulation
Narender Boggula, Banothu Bhadru, Kishore More
RP-HPLC was used to build sensitive and accurate procedures for establishing and verifying analytical methods for estimating levomilnacipran in bulk and pharmaceutical dose forms. The ratio of methanol to 10 mM dipotassium hydrogen phosphate buffer pH 6.5 in the mobile phase is 50:50 (v/v%). The working standard solution was 20 g/mL. With a flow rate of1-mL/minutes, an injection volume of 20 μL, a run time of 10 minutes, and a detection wavelength of 215 nm, the analysis was carried out on XBridgeTM C18 column 5 (250 x 4.6 mm). Readings of the precision study %RSD were found to be below the 2% limit. With a r2 of 0.998, it was concluded that the strategy was linear. The results showed that the levomilnacipran LoD and LoQ values were 1.42 and 4.75 μg/mL, respectively. The approach may be used to analyse levomilnacipran bulk and pharmaceutical formulations.

14. Method Development and Validation for the Determination of Sotorasib by LC-MS/MS Technique
Phani K Sunkara, Sreedhara Chaganty, K Ramakrishna
The main of the research work is to develop and validate a linear, precise and specific LC-ESI-MS/MS method for the quantification of sotorasib. Chromatographic resolution was achieved with ODS Zorbax (50 × 4.6 mm, 2.1 μ) C18 column and a mobile phase composition of methanol, 0.1% formic acid and ACN in the proportion of 50:15:35 with 0.5 mL/min flow of the mobile solvent system from the stationary column procedure was executed by monitoring the established ionic transitions of m/z- 561.09/316.84 for sotorasib and 478.09/451.08 for apalutamide internal standard in multiple reaction monitoring. The linear plot regression line was y = 0.0001x + 0.0011, with a correction coefficient (r2) of 0.9996. The %CV outcomes for matrix effect at low-QC and High-QC levels were 2.90 and 3.41%, respectively. The percentage average recoveries for sotorasib in high-QC (11.25 μg/mL), MQC (7.50 μg/mL) and low-QC (1.05 μg/mL) were 102.41, 98.07, and 102.41%, respectively. The obtained values were between 2.00 and 4.03% for the QC (0.375, 1.05, 7.50 and 11.25 μg/mL). The established technique was subjected for validation as per the food and drug administration (FDA) guiding principles and can be useful for the evaluation of sotorasib in biological samples in quality control, forensic and bioavailability studies.

15. A particular Separation Method Development and Validation of Nadolol and Bendroflumethiazide by using RP-HPLC
SVS Sumaltha, D Bharathi, Ramana Tamminana, P S Rao, P Kamala, Ramesh R Rudraraju
We have developed a simple, general, and reliable HPLC Method and validation for the simultaneous estimation of Nadolol and Bendroflumethiazide drugs according to (ICH) guidelines. Nadolol and Bendroflumethiazide peaks have been observed at a retention time of 1.757, and 3.208 minutes, respectively, and they have kept 5 minutes as a total run time. As per linearity results, the average correlation coefficient of nadolol and bendroflumethiazide is 0.999 which indicates they have good linearity, robustness, and stability.

16. Evaluation of the Effect of Some Plant Extracts as Antifungal Substances Isolated from Patients with Gingivitis and Endophthalmitis in Hilla City
Jehan Y Al-demirchi, Oras Kadhim, Abed J Kadhim, Mais M Al-Hamdani, Mohammed K Al-Hussainawy, Mohammad J Al-Jassani
During this study, 8 isolates of Candida yeast were isolated and diagnosed on CHROMagar, and Candida albicans was the most prevalent species by 75%. The inhibitory activity of plant extracts of adrak, cloves, green tea, and cinnamon was tested by disc diffusion test against C. albicans, C. krusei, and the antibiotics gentian stain, fluconazole, kenazole, nystatin were used for comparison. As well as using oral and dental cleaning products for comparison as well. The study showed that clove extract had a weak inhibitory activity at a high concentration, while extracts of green tea, cinnamon and mint did not show any activity in inhibiting C. albicans and showed that toothpaste had high activity in inhibiting yeast better than the plant extracts that did not show any inhibitory effect despite their use in high concentrations. We conclude from the current study that it is better to use toothpaste instead of herbs to get rid of gingivitis because it plays a major role in inhibiting Candida yeast.

17. Determination of Paraphenylenediamine in Hair Dyes Formulation Using Visible Spectroscopy
Gahtori Archana, Patni Pawnesh, Sehgal Tanya, Dimri Taniya
Paraphenylenediamine (PPD), which stands for para-phenylenediamine, is a substance commonly present in hair dyes and is a potent sensitizer and reported to have adverse effects, including skin rashes, allergies, etc. This research study introduces a newly developed and rigorously tested visible spectrophotometric technique for accurately measuring the quantity of PPD in hair dye products. The proposed method relies on a colorimetric reaction between PPD and Folin–Ciocalteu phenol (FC) reagent in the presence of sodium hydroxide (NaOH), which results in a PPD-Folin’s reagent complex that is blue in color. To create a standard calibration curve, various concentrations of PPD solutions within the range of 2 to 10 μg/mL, dissolved in 0.1N NaOH, were combined with 1.5 mL of FC reagent solution and scanned at 645 nm. The method was then used to estimate the amount of PPD in three marketed hair dye formulations. The technique demonstrated accuracy and precision, with a detection limit of 0.2445 μg/mL and a quantification limit of 0.7411 μg/mL. The level of PPD observed in three marketed formulations was between 10 to 12.5 μg/mL. During the study, it was observed that the black henna pack contained high concentrations of PPD.

18. Design of Experiment Enhanced Development and Validation of RP-HPLC Method for Analysis of Ascorbic Acid and Rutin
Srividya A, Sreedevi A, Swarupa B
This work intends to develop a QbD-based RP-HPLC method and validate rutin (RU) and ascorbic acid (ASC) in combined tablet dosage form. The method is optimized by the central composite design. The independent variables chosen are mobile phase ratio and pH. The dependent variables are retention time for RU (R1), retention time for ascorbic acid ASC (R2), and resolution (R3). Analysis of variance revealed that the method parameters were significant (p <0.05). Waters Alliance-e2695 [C18 (150x 4.6 mm, 3.5)] was used to separate rutin and ascorbic acid using a mobile phase Acetonitrile: Hexane Sulphonic Acid (pH-2.5/OPA) in a 70:30 ratio, the selected wavelength was 215 nm. Method validation and degradation studies were performed ICH guidelines are followed. The approach was determined to be easy, suitable, accurate, precise, and robust for quantitative analysis of ascorbic acid and rutin.

19. Development of Stability Indicating Method for the Quantification of Futibatinib in K2EDTA Human Plasma by LC-MS/MS
P Jogeswararao, DVRN Bhikshapathi
A sensitive, accurate, and linear LC-MS/MS method for the quantification of futibatinib in human plasma K2 ethylene diamine tetraacetic acid (EDTA) was developed. A Phenomenex C18, 150×4.60 mm, 2.1 μ column, 0.1% HCCOH, ACN and methyl alcohol (13/67/20, v/v/v) mobile solvent system at 0.8 mL/min was employed for the isolation of components.10 μL. of volumes were employed to isolate the peak responsess within 2.0 minutes at 40 ± 5ºC of oven temperature. Analyte retention was 1.261 minutes and ISTD of 1.292 minutes. Throughout the process of validation, each of the four calibration curves exhibited linear behavior for standards with concentrations ranging from 0.16 to 3250 ng/mL. Validation showed an r2 = 0.9997. At MQC, HQC, and LQC concentrations, futibatinib had 98.49, 99.35, and 98.47% mean recovery. Every QC level had a mean recovery of 90.51% and a %CV of 3.06. All of the control solutions had back-calculated concentration values that were accurate between 94.61 and 98.86% of the time. The range of %CV of back-calculated values for all quality control samples were in the range of 0.6 and 4.63, which is within the acceptable range of 15%. The developed method can be applied successfully for the quantification of the Futibatinib in biological matrices.

20. Synthesis and Evaluation of Novel Quinazolin-4-(3h)-one Analogues for their Anti-Inflammatory Activity
RS Kulkarni, NK Sathish, AA Kempwade, SA Kavatagimath
New 2, 3-disubstituted quinazolin-4-(3H)ones was conceived and synthesized through the substitution of various primary amines at the 3-position and a range of aldehydes at the 2-position. These compounds were characterized using elemental analysis, IR spectroscopy, 1H NMR spectroscopy and MS. Subsequently, the anti-inflammatory activity of these newly developed quinazoline derivatives was investigated by in-vitro protein denaturation method. In-vitro studies revealed that compounds QB1, QB2, QB4, QB8, QB9, QF1, QF3, QF4, QF8 and QF10 have significant anti-inflammatory potential. In-vivo anti-inflammatory properties of QB2 and QF8 were tested in carrageenan-induced paw edema. Research findings demonstrated that compounds QB2 and QF8 have significant anti-inflammatory properties.

21. Methocarbamol Transferosomal Gel For Topical Delivery: In-vitro, Ex-vivo and In-vivo Evaluation
Hima Bindu E, GV. Radha
Because of their capacity to permeate across the stratum corneum’s barriers to penetration, transferosomes are one of the vesicular transporters that have recently attracted a lot of research and attention. The current study aimed to analyze and improve methocarbamol transferosomal transdermal gels. Reverse phase evaporation was used to create thirteen different formulations of methocarbamol-loaded transfersomes. Using face-centered central composite designs, the influence of independent process variables, like soy lecithin content and surfactant concentration, on dependent variables, such as entrapment effectiveness and the vesicle size of methocarbamol transfersomes, was assessed. The ex-vivo permeation flux of methocarbamol and the lipid to surfactant ratio/skin absorption efficiency of the drug and transferosomal gels were optimized. The optimized formulation showed an entrapment efficiency of 95%, a vesicle diameter of 428 nm, a drug content of 96.6% and a zeta potential of −28.9 mV. In-vitro and ex-vivo drug release rate in optimised gels was found to be 86.43 and 84.12% for 24 hours, respectively. This tranferosomal delivery method for transdermal methocarbamol may be preferable to the standard of care.

22. Stability Indicating an LC-MS/MS Method Development and Validation for the Quantification of Capmatinib in Human Plasma
Hema, Naresh Panigrahi
A linear and accurate liquid chromatographic tandem mass spectrometric (LC-MS/MS) technique for the quantitation of capmatinib in plasma was developed and subjected for validation. Canagliflogin was employed as an internal standard (IS). Extraction of plasma was executed utilizing 5 mL of ethyl acetate solvent. Analysis was performed Zorbax ODS (50 mm × 2.1 mm x 3 μ) stationary phase at room conditions and a movable solvent composition of 0.1% HCOOH, acetonitrile and methyl alcohol (15:50:35). The flowing rate of the movable phase was 0.4 mL/min. Drug and IS were identified in positive mode of ionization with electrospray mode to get the mass transitions of (m/z): Capmatinib, 413.15/386.14 and canagliflogin (IS), 445.15/267.12. The correlation between capmatinib concentrations and their respective peak proportions to canagliflogin was a straight line over 0.2 to 3200 ng/mL concentration levels. Intraday and inter-day precisions were ≤5.18% for capmatinib. Inter and intraday bias were within the range of −4.17 to 4.53%. The mean measured extraction recovery of capmatinib was 99.23%. Recovery of IS was 98.31%. Capmatinib was subjected for long-term, freeze thaw, bench top, short-term stability, auto-sampler, dry extract, and stock solution stability at low QC and high QC levels and it was stable at all these conditions. The established technique can be utilized to regularly quantitfy of capmatinib in plasma samples in industries, forensic labs, and clinical research organizations.

23. Study of the Combined Effect of Silymarin, Quercetin, and Hesperidin on 3 nitro Propionic Acid-induced Rat Model of Huntington’s Disease
Arti A. Bhimanwar, Aarti P. Nikam, S. P. Dhamane, S. P. Barangule
This investigation proposes to encapsulate how the combined effects of silymarin, quercetin, and hesperidin impact the abilities of rats with Huntington’s disease (HD). Male Wistar rats were administered 3-NP through intraperitoneal injections. Various behavioral measures, including muscle grip strength, locomotor activity, and a string test, were assessed. After 22 days, assessments of lipid peroxidation, glutathione levels, superoxide dismutase, catalase, succinate dehydrogenase(Complex II) activity, lactate dehydrogenase (Complex IV) activity, and the determination of interleukin-6 levels was performed. Administering 3-NP dosage of 10 mg/kg body weight for 21 days outcomes in a substantial rise in learning and memory impairments that closely resembled those seen in HD. Within specific treatment groups, it was observed that quercetin significantly enhanced muscle coordination and demonstrated a noteworthy upsurge in various behavioral measures. After silymarin, quercetin, and hesperidin were combined, there were significant improvements in key biochemical markers such as glutathione (GSH), superoxide dismutase (SOD), catalase (CAT), and SDH activity induced by 3-NP. These improvements led to a decrease in neuronal damage and apoptosis in brain. Each bioflavonoid successfully reinstated the stages of biochemical markers, for example, GSH, SOD, CAT, and SDH, while reducing the activity of malondialdehyde (MDA) and lactate dehydrogenase (LDH). However, after these bioflavonoids were combined, their collective impact was more potent Compared to what each achieved individually.

24. Recovery of Stressed Escherichia coli Culturability using Selective Media with Penicillin Binding Proteins for Bioburden Testing
Baswa J Kumar, R G Prasuna
This study aimed to assess the effectiveness of selective media enriched with Penicillin-binding proteins (PBPs) in bioburden testing and the recovery of stressed Escherichia coli. Five distinct E. coli strains were subjected to experimentation utilizing two antibiotics to induce stress, simulating real-world scenarios where bacteria face various stressors, including antibiotics. The deliberate stress induction aimed to observe how stressed bacteria respond and recover in the presence of PBPs, vital cell wall components targeted by antibiotics. Multiple antibiotics ensured a comprehensive evaluation of stress responses. PBP1 tended to have a milder inhibitory effect on bacterial growth compared to both PBP2 and PBP3 across various growth media and strains. PBP2 demonstrated variable effects, displaying a nuanced impact depending on the growth medium and strain. In contrast, PBP3 consistently exerted a stronger inhibitory effect on bacterial growth. The strain of E. coli exhibited a significant influence on growth characteristics, reflecting strain-dependent responses to experimental conditions. Growth media and specific PBPs also displayed notable effects on colony forming units (CFUs) and percentage recovery (PR). Modified media generally supported higher CFUs and PR compared to standard media, showcasing the importance of media composition. Buffer choice also significantly impacted CFUs and PR, underlining the need for careful buffer standardization. Overall, the type of PBP used significantly affected E. coli colony numbers, as indicated by a highly significant p-value (p≈2.04×10-16). This study’s insights into the impact of selective media, PBPs, and bacterial strains on stressed E. coli recovery contribute to optimizing recovery protocols in microbiological studies. Comparisons between penicillin and cefixime treatments revealed higher CFU values in modified media, indicating their efficacy. Different PBPs showcased variations in CFU and PR, emphasizing their role in stressed E. coli recovery. The study sheds light on the multifaceted interactions between antibiotics, PBPs, media, and bacterial strains, vital for understanding antibiotic responses. These findings provide critical insights into designing effective recovery strategies and advancing microbiological studies.

25. Extraction, Isolation, Characterisation and Pharmacological Investigations of Beta Escin from Horse Chest Nut Seed Extract
Poonam Chougule, Kailasam Koumaravelou, Nilesh Chougule
Horse chestnut seeds (Aesculus hippocastanum) have long been recognized for their potential therapeutic properties, particularly due to the presence of bioactive compounds like beta-escin. This study aimed to comprehensively explore the extraction, isolation, characterization, and pharmacological investigations of beta escin from horse chestnut seed extract. Beta escin was extracted from horse chestnut seeds through a series of solvent extraction and purification steps. The isolated compound was then characterized using various analytical techniques, including UV, IR, DSC, X-RPD and GC/MS. Pharmacological studies were carried out to evaluate beta-escin’s possible medicinal applications. In this anti-inflammatory investigation, it was found that the carrageenan-induced reduction in swelling in diclofenac gel begins after 30 minutes, with a value of 11.71%, whereas the effect of escin gel takes 60 minutes to manifest, with a value that is slightly lower at 4.55%. Pharmacological research demonstrated a variety of positive benefits, such as anti-inflammatory, antioxidant, and vascular protecting qualities, which may have prospective uses in the treatment of edema and chronic venous insufficiency.

26. Comparative Characterization of Reference Market Product and Generic Product Developed using Reverse Engineering Methodology
Jailani S, C K Dhanapal, Noohu A Khan
The present study is a comparative analysis between the reference market product, Xarelto® 20 mg film-coated tablets, and a generic product developed using reverse engineering methodology, employing low-shear ethanolic granulation. The primary objective in formulating and optimizing this generic product was to attain a formulation that exhibits both physical and chemical stability, closely resembling the innovator or market reference drug product. Both reference and generic products were evaluated using FTIR, TGA, DSC, XRD, SEM, EDX/EDS, Raman mapping, Raman imaging and contact angle measurement studies and were compared. Similar characteristic peaks were observed in the IR spectra of the generic product (RX-LS [AH]) to that of the reference product. Similar crystallinity was detected between reference and generic products. The TG-DSC analysis confirmed the presence of a similar endothermic peak of the generic product to that of the reference product. SEM images showed the presence of deformed granules in both, generic and reference products due to the compression force during tablet production. The specific and major elements present in both samples were C, N, O, Na, Mg, S and Cl. The API and excipient distribution within the reference product and the generic product is closely similar confirmed through the Raman study. Test (θ = 17.3) and reference products (θ = 17.9) showed contact angles around 17 degrees, it indicates that both products have similar wettability capacity, in other words, similar solubility and dissolution behavior. The current study demonstrated the excellent similarity of generic Rivaroxaban 20 mg film-coated tablets with reference products. The exactly similar characteristics of generic products will definitely boost confidence of successful bioequivalence studies and reduce developmental cost and time as there is no a chance of product failure which will lead to redevelopment.

27. Effect of Coadministration of Hydroalcoholic Extracts of Aegle marmelos Leaves and Tamarindus indica Seeds on Streptozocin-Nicotinamide Induced Type- 2 Diabetic Rat Model
Jay Prakash, Smita Shenoy, Archana P Raghavendra, Krishnadas Nandakumar, Anoop Kishore
It is difficult for doctors to control hyperglycemia in type 2 diabetes patients without having an effect that is too detrimental to the patient, despite the advancements that have been made in diabetes medications. Because of their adaptability and capacity to lower blood sugar with very few unintended side effects, herbal preparations are quickly gaining in popularity worldwide. In this study, hydroalcoholic extracts of Tamarindus indica seeds and Aegle marmelos leaves were tested to determine what kind of effect they had on a model of diabetes carried out on rats.
For the purpose of this investigation, 54 male Sprague Dawley (SD) rats were used as participants. Group I comprised of six people who did not have diabetes and were considered to be in good health. Intraperitoneal injections of streptozocin(55 mg/kg) and nicotinamide (NAD) (120 mg/kg) were used to induce diabetes in the remaining animals (n = 48). Following that, we divided them up into a total of eight distinct categories. Animals in groups IV and V were given AM at doses of 25 and 50 mg/kg/day, animals in groups VI and VII were given TI at doses of 25 and 50 mg/kg/day, animals in groups VIII and IX were given a combination of the two extracts (AM25+TI25 & AM50+TI50), while diabetic animals were used as controls in group II. A positive control consisting of metformin given at a dose of 200 mg/kg per day was utilized in group III.
When compared to the diabetic control group, the fasting blood glucose levels and the area under the curve (AUC) of the oral glucose tolerance test were lower in all treatment groups. When compared to the metformin groups, the performance of the extract combination groups was considerably superior (p 0.01). Additionally, as compared to the diabetic control group, all of the treatment groups had significantly reduced levels of MDA and hepatic G-6-Pase activity (p 0.001).
In terms of effectiveness, the combination group performed much better than the metformin group despite the fact that all pharmacological groups showed significant increases in body weight, relative liver weight, HDL level, and liver glycogen content in comparison to the diabetic controls. (p < 0.05). When compared to the diabetic control group, all therapy groups showed an increase in G-6PD activity (p 0.001), catalase levels (p 0.001), and glutathione (GSH) levels (p 0.05).
In STZ-induced type 2 diabetic rats, a combination of extracts (AM50+T150) demonstrated the best improvement after 30 days of therapy when compared to metformin and hydroalcoholic extracts (AM and TI) alone. This was the case even when both treatments were administered separately. There was no difference in the circumstances no matter which extracts were utilized.

28. Chemoprevention of DMH Induced Colon Carcinogenesis by Combination Administration of Lactobacillus acidophilus, Calcium and Moringa oleifera Leaves Extract
Kumawat Mrudula, Une Hemant
Colon cancer has become one of the most prevalent and deadliest type of cancer in the globe in recent years. In order to prevent colon cancer triggered by DMH (1,2-dimethyl hydrazine hydrochloride), this study was to investigate the potential chemopreventive effects of calcium citrate, Lactobacillus acidophilus, and Moringa oleifera leaf extract. Sprague Dawley rats were randomized into 10 different groups and received subcutaneous injections of DMH (30 mg/kg) for 8 weeks of duration. Treatment groups were served for 4 weeks, 5-Flurouracil (20 mg/kg) was dosed with two intraperitoneal injections in a week and. L. acidophilus (1 × 109 cfu/kg p.o.), calcium citrate (2 mg/kg p.o.) and hydroalcoholic extract of M. oleifera leaves (100 and 200 mg/kg p.o.) were used for daily. All animals were killed after the completion of treatment, and colonic tissues were assessed for biochemical and histopathological parameters. DMH treatment-induced cellular and systemic oxidative stress results in depletion of cellular antioxidant enzyme levels with an alteration in hematological counts. The colonic tissues had a loose histoarchitecture with severe cellular infiltration, edema in the epithelium, and a moderate nuclear/cytoplasmic ratio, goblet cells. Combination treatments of L. acidophilus (LA), Calcium citrate (CC), and hydroalcoholic extract of M. oleifera leaves (ME) showed positive improvements in antioxidant enzyme levels, hematology count, and colonic tissue histoarchitecture. From outcomes of the present work concluded that a combination treatment of L. acidophilus, calcium citrate and a hydroalcoholic extract of M. oleifera leaves showed chemo-preventive effects against colon cancer triggered by DMH.

29. Formulation Development and Characterization of Acitretin Proniosomal gel: In-vivo Exploration against Imiquimod-induced Psoriasis in Experimental Animals
Bhushan R Gudalwar, Tarkeshwar P Shukla
The main purpose of this study was to prepare and evaluate acitretin proniosomal gel (APG) and find out if the antipsoriatic formulation could prevent Imiquimod (IMQ) induced psoriasis in experimental animals. APG was developed and by coacervation phase separation method. Cholesterol and soya lecithin was used as membrane modifiers and tween 80 and span 60 as non-ionic surfactants. Characterization of the prepared proniosomal gel revealed that the optimized batch APG3 presented excellent formulation characteristics like the viscosity of 9710 ± 1.24 cps, rate of spontaneity as 13 ± 0.86, % entrapment efficiency of 94.91 ± 0.51, average hydrodynamic diameter of niosomes as 345.7 nm, polydispersibility index as 0.159 and ZP of -2.3 mV. In-vivo animal study of the optimized batch APG3 was performed along with biochemical estimations of oxidative parameters as glutathione (GSH), superoxide dismutase (SOD), malondialdehyde (MDA) and catalase; also, TNF-α, IL-6 were estimated using ELISA sandwiched. Histopathological estimation along with psoriasis area severity index (PASI) scores in the IMQ-induced psoriatic model presented a significant fall in the scoring after treatment with APG3 compared with a psoriatic group. Primary dermal irritation scoring was also evaluated on Sprague Dawley rats. The results presented a considerable decline in skin irritation score compared with a psoriatic group. Also, the levels of GSH, SOD and catalase were increased in APG3 treated group as compared with a psoriatic group. While MDA level is decreased after topical treatment with APG3 compared with a psoriatic group. In conclusion, the optimized APG3 showed promising pharmacological effects in the treatment of psoriasis.

30. To Evaluate the Epidemiology, Etiology, Risk Factors and Treatment Management in Chronic Kidney Disease in Children, Adult and Geriatric Patients in a Tertiary Care Teaching Hospital in Nellore
Naveena B, Ronald Darwin
Chronic renal failure is a life-threatening disease to society. The study was conducted from October 2021 to June 2023 the study was done in the Nephrology inpatient ward, Vijaya Super Speciality Hospital, Pogathota Nellore, Andhra Pradesh. The study design is a cross-sectional for epidemiology and prospective observational study-1 for etiology, II-risk factors, III-treatment management. The sample size are 381 subjects in that children are 51 subjects, adult 171 subjects and geriatric are 159 subjects. The male are 199 volunteers and the female are 182 volunteers with chronic kidney disease (CKD). The result of this study was the epidemiology factor more in adults (45%) when compared to children (13%) and geriatrics (42%). In the sex parameters are less affected to females (48%) and males (52%) are more affected with chronic kidney disease. The etiology causes in children are glomerulonephritis, adults diabetes mellitus (DM) and geriatrics pyelonephritis these are the main causes for chronic renal disease when compared to other etiological causes. Risk factors in children are congenital defects, adult are diabetes mellitus and geriatric are kidney disease these are the risk factors to the renal failure patients. In treatment management, hemodialysis is the most effective treatment to adults when compared to children’s and geriatric eng stage renal failure disease. The conclusion of this study initially may rectify causes and risk factors of the patients may not high prevalent in end-stage renal failure disease it not cause hemodialysis therapy and renal transplantation in children, adults and geriatric patients.

31. Phyto-pharmacological Investigation of Plumbago zeylanica for Memory Enhancing Activity
Pavan K Padarthi, Kumara S Samanthula, Pushpendra Kumar, Venkateswara R Jallepalli, Mangirish Deshpande
Objective: The main goal was to assess the possible memory-enhancing effects of Plumbago zeylanica root extract on Wistar rats. Materials and Methods: Extract of P. zeylanica roots evaluated for memory enhancement by Morris water maze (MWM) and elevated plus maze (EPM). Here, the parameter examined was transfer latency (TL). Results: There was a dose-dependent decline in TL when P. zeylanica root extract was administered, as compared to the control. Conclusion: The observed dose-dependent reduction in transfer latency provides compelling evidence of the extract’s potential in countering neurodegeneration and affirming its nootropic capabilities.

32. Isolation, Characterisation and In-vitro Antioxidant activities of Flavonoid Compounds from Methanolic fraction of Aspidopterys indica
Udaya Chandrika P, Sunitha K
Aspidopterys indica belongs to the family Malphigiaceae and is used to treat hypertension and skin diseases. In the current investigation, methanolic extract was fractionated using vacuum liquid chromatography, and the methanolic fraction was subjected to column chromatography for isolation and characterized by fourier transform infrared spectroscopy (FTIR), Mass, proton nuclear magnetic resonance (1H-NMR), and carbon-13 nuclear magnetic resonance (13C-NMR) spectroscopy. The compounds isolated were assessed for their in-vitro DPPH antioxidant activity. Two compounds, AI-1 and AI-2, established after spectral analysis, were identified as catechin flavan-3-ol and isoorientin flavone C-glucoside. The results indicated that the compounds showed concentration-dependant DPPH scavenging action and IC50 of catechin 93.66 μg/mL, isoorientin 92.09 μg/mL. This study concludes that catechin and isoorientin with known antioxidant potential were isolated from the methanolic fraction of A. indica, which could effectively manage oxidative stress-related diseases.

33. Anti-Angiogenic Effect of Clerodendreme inerme Leaves Extract
Mrunalini D Kotagiri, G Shiva Kumar
Clerodendrum inerme, a medicinal plant, exhibits diverse pharmacological properties. Various species within the Clerodendrum genus have been traditionally utilized in indigenous medical systems and folk remedies. This study intended to scrutinize the anti-angiogenic possibility of CI through in-ovo, in-vitro, and in-vivo approaches.
The screening methods employed include the chick chorioallantoic membrane test (in-ovo), sponge bud technique (in-vivo), as well as in-vitro assays for cell migration, cell proliferation, along with morphogenesis. Statistical analyses involved Dunnett’s test for mean comparisons, utilizing one-way ANOVA.
In the chick chorioallantoic membrane assay, both angiogenic score and branching points were evaluated. Notably, CI exhibited noteworthy antiangiogenic effects.
In the sponge implantation technique, CI at specified dosages resulted in a substantial reduction in sponge weights, the formation of new vessels, and hemoglobin levels. The antiangiogenic effects were particularly pronounced with increasing doses.
Furthermore, on endothelial cells, C. inerme demonstrated a dose-dependent decrease in migration, proliferation, and tube length, indicating potent antiangiogenic properties.
In summary, this research underscores the considerable antiangiogenic potential of CI by various assays.

34. Isolation, In-silico Studies, and Biological Evaluation of Higenamine from Annona squamosa L. against Breast Cancer
Amol D Shailaja, Jaykumar S Pramodkumar
The efficacy of Annona squamosa L. in cancer treatment has been documented, inspiring the authors to investigate the plant further for potential novel anticancer compounds. Therefore, the current study aimed to isolate and characterize Higenamine from leaves extract of A. squamosa L. and studied for the in-vitro cancer cell line and molecular docking. The high performance liquid chromatography (HPLC) and thin layer chromatography (TLC) method development of A. squamosa L. leaves extract furnished Higenamine of which characterization was established by HPLC, infrared radiation (IR), liquid chromatography-mass spectrometry (LC-MS) and its acute toxicity study and cytotoxic properties using MCF-7 cell lines by MTT assay were assessed. Molecular docking was done using Auto Dock Vina software to validate the anticancer activity. The extraction batches by ultrasonication and maceration methods showed good results using 80% methanol. Acute toxicity studies, after a single dose (2000 mg/kg) administration of methanolic extract don’t show clinical symptoms of toxicity and mortalities. From the extract, Higenamine was eluted and the dried fraction showed 66% of enrichment of Higenamine. The developed HPLC and TLC methods showed Higenamine (HGN) peak at 6.21 minutes band at Rf 0.61, respectively. The isolated compound was identified as Higenamine with FTIR spectroscopic analysis which revealed various characteristic band values with functional groups. HPLC-MS showed m/z at 272.1 (M+H+) corresponding to the molecular formula C16H17NO3. The IC50 value for Higenamine was 42.39 μg/mL were observed in MCF-7 breast cancer which was better than 5-Fluorouracil having 39.22 μg/mL. In-silico studies explored that higenamine showed good binding affinity to breast cancer PDBIDs and forms a stable complex. Furthermore, absorption, distribution, metabolism, and excretion (ADME) properties of isolated compound was calculated using the Swiss ADME online tool in which higenamine was found to have a good pharmacokinetic profile as compared with 5-fluorouracil and doxorubicin. Higenamine has been isolated and identified as a potential anticancer agent. Further research can explore its effectiveness through pharmaceutical formulation and in vitro cell line studies.

35. Diuretic Activity of Hydroalcoholic Extract of Peristrophe bicalyculata (R.) Nees. Leaves in Saline Loaded Rats
Sumeet Dwivedi, Mahavir Chhajed, Gurmeet Chabra, Sujit A Jadhav, Gaurav Goyanar, Navin K Choudhary
Peristrophe bicalyculata (R.) Nees. (PB) is one of the most widely medicinal plants used in ancient folklore to treat a number of diseases. In the present investigation, the diuretic activity of hydroalcoholic extract of leaves of selected plant was evaluated in saline-loaded rats. Rats weighing in between 180 to 200 gm of either sex were taken for the present study and concentration of urinary NA+K+ and Cl- was determined to access the memorandum of association (MOA). The hydroalcoholic extract of PB leaves at the test dose of 250 mg/kg bw showed significant diuresis in 3 hours while at the test dose of 500 mg/kg bw produced substantial diuresis at the end of 4 hours.

36. Pharmacological Study of the Anti-ulcer Efficacy of Saraca asoca Leaves Extract in Various Ulcer-inducing Models in Rats
Shivangi Saxena, Vishal Dubey, Megha Tiwari, Komal Yadav, Ashwani Kumar, Shilpi Devi
The ulcer is a common gastrointestinal disorder that is seen among many people. It is basically an inflamed break in the skin or the mucus membrane lining the alimentary tract. Ulceration occurs when there is a disturbance of the normal equilibrium caused by either enhanced aggression or diminished mucosal resistance. It may be due to the regular usage of drugs, irregular food habits, stress and so forth. In the present investigation anti-ulcer action of Saraca asoca leaf extract was determined in rats and results suggest that it possesses significant activity.

37. Preformulation: Development of Solubility, UV and FTIR estimation of Phytobioactive Antifungal Compounds Allicin
Praveen K Yadav, Hemant Swami
When developing new dosage forms, compatibility tests between excipients and active pharmaceutical ingredients (API) are essential for preformulation. An API’s chemical composition, stability, and bioavailability, as well as its safety and therapeutic efficacy, can all be affected by possible physical and chemical interactions with its excipients. Solid dosage forms are typically less stable than the constituents of their API. Even though testing for API-excipient compatibility is important, there isn’t a universally accepted method for assessing these kinds of interactions. The oily, yellow material that gives garlic its distinct smell is called allicin. It’s a thioester of sulfenic acid. Another name for it is alyl thiosulfinate. Its interaction with proteins containing thiols and antioxidant activity are what give it its biological activity. In the present work various preformulation parameters of allicin was estimated and reported.

38. Stability Indicating Reverse Phase Ultra Performance Liquid Chromatography Method Development and Validation for Amiloride and Hydrochlorothiazide Tablet in the Presence of Degradation Products and Application to Green Analytical Principles
Neetu Sabarwal, Suman Jain, DD Agarwal
Amiloride (AML) and hydrochlorothiazide (HCTZ) combination is used alone or with other medicines to treat high blood pressure (hypertension). The present article provides the development and validation of an reverse phase ultra-performance liquid chromatography (RP-UPLC) approach for the quantification of AML, HCTZ, and related impurities in pharmaceutical dosage forms. The analytical column used for the separation of impurities is the Waters X bridge C18 3.5 μm (50 mm X 4.6 mm). Used 0.1% formic acid and ethanol as MP in an isocratic mode with 0.3 mL/min as flow rate and 3 μL as injection volume, at 254 nm as detection in UV and 12 minutes as total run time. The samples were prepared specifically to undergo forced degradation, which involved subjecting them to hydrolysis, oxidation, thermal, and photolytic conditions. The technique underwent validation by the principles set forth by the ICH Q2 guidelines. The validation confirmed that the method possesses specificity, linearity, ruggedness, robustness and accuracy. The methodology employed exhibited a linear relationship extending from 10 to 150% for all impurities. The recovery analysis was conducted throughout a range of concentrations, starting from 10 to 150% concentration. The average recovery value was determined to be within acceptable limits. The evidence of degradation and the findings of the verified study suggest that the nature of the subject under investigation is stable. Hence, this approach might be employed within the domains of pharmaceutical research and development and quality control departments. Green analytical chemistry tools are used to assess the method’s greenness and calculated using GAPI, AGREE and ecological-scale and found excellent green of >75%.

39. A Retrospective Study of Documentation Shortfalls Mentioned in USFDA Warning Letters Issued to India Pharmaceutical Industries
T Sudheer Kumar, Raju Kamaraj
The pharmaceutical industry is an indispensable sector that ensures patients have access to safe and effective medications. Therefore, it is essential that companies comply with regulatory standards and maintain accurate and complete documentation practices. This study will investigate the documentation violations cited in warning letters sent to Indian pharmaceutical companies between 2010 and 2022. The analysis will focus on identifying the most common documentation deficiencies and the impact they have on the pharmaceutical industry in India. The findings of this research will provide Indian pharmaceutical firms with valuable insights. to improve their documentation practices and ensure compliance with regulatory standards. This information will be useful for stakeholders in the pharmaceutical industry, including regulatory agencies, pharmaceutical companies, healthcare professionals, and patients. By understanding common documentation violations, companies can take proactive steps to prevent them and avoid regulatory penalties. The findings of this study will aid policymakers and regulatory agencies in devising strategies to enhance the integrity of pharmaceutical industry documentation practices. The findings will also inform the development of educational and training programs for pharmaceutical companies, which can help them enhance their documentation practices and ensure compliance with regulatory standards.

40. Utilizing In-vitro Techniques to Evaluate the Antioxidant Potential of Vitex negundo Leaves Extract
Monali B Wawre, Dipak Khobragade, Dharmendra Mundhada, Harshada Kayarkar
In this study, Vitex negundo leaf extracts were screened for phytochemical composition and antioxidant activity. Antioxidants are essential for preventing and battling oxidative stress and, ultimately, ailments it leads to. The study that employed FRAP, nitric oxide scavenging, superoxide radical scavenging, 1,1-diphenyl-2-picrylhydrazyl radical (DPPH) to test the antioxidant activity of V. negundo leaves extract revealed antioxidant activity. The result of the phytochemical examination of the extract shows that entity of total phenolic content, reducing sugar, saponin. The findings suggest that this herb can be a very beneficial component for conditions that call for antioxidant therapy and are brought on by oxidative stress. The V. negundo shows the average TPC of 235.24 GAE/g weight of ethanolic extract. The TFC in the ethanolic extract was found to be 157.53 mg QE/g of extract. Outcomes demonstrated the significant antioxidant activity of ethanolic extracts of V. negundo leaves.

41. A Flavonoid-rich Fraction of Alternanthera pungens Ameliorates Hyperglycaemia -mediated Memory Dysfunction in Diabetic Rats
Sayyada S Momina, Kumaraswamy Gandla
The Central Nervous System (CNS) undergoes alterations due to persistent hyperglycemia and cholinergic dysfunction, leading to cognitive impairment associated with diabetes (T2DM). Animal studies have shown that acetylcholinesterase (AChE) inhibitors and anti-diabetics are effective. Considering the impressive potential of natural products in treating DM and AD, the present research set out to assess the neuroprotective effects of a methanolic extract of Alternanthera pungens (MEAP) against cognitive impairment in mice caused by hyperglycemia. Hence, we used the mobile workforce management (MWM) and enterprise performance management (EPM) assays to analyze for cognitive impairment in diabetic rats. 30 days after the initiation of T2DM, rats had hyperlipidemia, increased escape latency in EPM tasks, and decreased time spent in the TSTQ during probe trials in the MWM. They also displayed notable and persistent hyperglycemia throughout training trials. Changes in blood glucose, lipid, and liver profiles, as well as performance in MWM and EPM tests, were averted in STZ-induced T2DM rats treated with MEAP (200 and 400 mg/kg). In a separate series of experiments, flavonoids (i.e., quercetin and rutin) were detected by the standardization of the extract using high performance thin layer chromatography (HPTLC). Inhibitory actions against alpha-amylase and alpha-glucosidase demonstrate that both of these flavonoids are potent antidiabetic agents that reduce intestinal glucose absorption. Lastly, the inclusion of these flavonoids in the extract from A. pungens is responsible for its action, suggesting that it may provide a novel strategy for preventing cognitive deterioration in diabetes.

42. Extraction, Phytochemical Screening and HPTLC Analysis of Fenugreek Gum for Analysis of Different Phytoconstituents
Pravinkumar D Lade, Neelam Singla
Fenugreek gum is a natural polysaccharide that has been explored for various biomedical applications. The present study investigated the phytoconstituent profile of fenugreek gum, revealing it as a potent source of diverse bioactive compounds. The analysis encompassed steroids, fats and oils, alkaloids, proteins, saponins, tannins, phenolics, flavonoids, and carbohydrates. Extraction using methanol and aqueous solvents demonstrated the highest concentration of phytoconstituents, underscoring the efficacy of these solvents in isolating bioactive components from fenugreek. Further exploration involved the determination of Rf values and percentage area in chloroform, petroleum ether, and chloroform extracts, providing a comprehensive identification of the mixture’s components. The results suggested a rich and varied chemical composition in fenugreek gum, offering potential applications in diverse fields owing to the presence of steroids for physiological effects, fats and oils for nutritional benefits, alkaloids with potential pharmacological properties, proteins for cellular functions, saponins for their soap-like properties, and tannins and phenolics as antioxidants. Additionally, the presence of flavonoids and carbohydrates adds to its nutritional and medicinal value. The study’s findings contribute valuable insights into the phytochemical composition of fenugreek gum, shedding light on its potential applications in the realms of medicine, nutrition, and industry. The identification of optimal extraction methods and the characterization of phytoconstituents lay the foundation for future research and utilization of fenugreek gum as a versatile and valuable natural resource. Overall, this investigation underscores the significance of fenugreek gum as a rich repository of bioactive compounds with diverse potential applications across various domains.

43. New Validated LC-MS Method Development and Estimation of Nitrosamine impurities in Canaglifozin
Mubarakunnisa Mohammed, Gandhimathi R
Background: Canagliflozin is most prescribed anti-diabetic drug, as diabetic drugs are consumed daily there may be a chance of consuming nitrosamine impurities beyond their limits hence, the Food and Drug Association (FDA) recommends checking for carcinogenic impurities in routine use drugs. Aims and Objectives: The study aims to simultaneous estimation of 4 nitrosamines (NMDA, NEIA, NIEA, and NDIPA) by liquid chromatography-mass spectrometry (LCMS) to detect the limit of detection (LoD) and limit of quantitation (LoQ). estimation of these impurities (NMDA, NEIA) in canagliflozin tablet dosage form with specificity parameters. Methods: Drug canagliflozin was collected from hetero labs, methanol, LC-MS grade acetonitrile, formic acid four impurities (NMDA, NEIA, NDIPA, NIEA) purchased from Merck Pharmaceuticals Mumbai. The Zorbax SB C18 column (250 x 4.6 mm, 3 mcm) is used as the stationary phase, 0.1% formic acid and acetonitrile in the ratio of 70:30 is used as the mobile phase, methanol is used as diluent flow rate was maintained at 1-mL/min, the injection volume was fixed to 10 mcl, which is run at 10 minutes. The electron ionization ion source, multiple reaction monitoring, and acquisition mode is used for the study. The time required for the solvent delay and detector off is 4 and 9.5 minutes, respectively. The product ions peaks of impurities were observed at 44 for NDMA, 99 for NEIA. Results: The %RSD for the peak areas of NDMA, NEIA obtained from six replicate injections of standard solutions were 2.5, 9.8, 1.4 and 7.7, respectively. The %recovery of NDMA and NEIA were within the limit. The %RSD for the results obtained from the method precision study was within the limit. Conclusion: The above observations indicate that the LC-MS method meets the acceptance criteria for the parameters selected for the validation study. Hence, the method is suitable for the determination of NDMA, NEIA in a Drug Substance by LC-MS.

44. A QbD Assisted Bioanalytical Method Development and Validation for Simultaneous Estimation of Montelukast and Bilastine by LC-MS Technique
D Gnanasekaran, R Gandhimathi
This study describes how to use internal standards (IS) under the Analytical Quality by Design (AQbD) methodology to measure montelukast and bilastine in artificial rabbit plasma. The protein precipitation method was used for sample preparation and extraction. The chromatographic analysis was performed on the processed materials. The measurement range of the calibration was between 2 to 40 ng/mL for Bilastine and 1 to 20 ng/mL for montelukast. Optimizing mobile phase composition, flow rate, and pH were used to determine peak area and retention time. A significant reduction in method variability was observed as a result of the method of experimental design during optimization, and this enhanced the stability of the technique. A validation study demonstrated linearity, accuracy, precision, selectivity, sensitivity, and stability for estimating bilastine and montelukast in rabbit plasma using the developed method. The chemical composition of the drug was not altered during tests on its stability in human plasma. Overall, the investigations showed that the established approach is straightforward, reliable, and affordable for use in regular pharmacokinetic and bioequivalence research.

45. Formulation, Optimization, and Evaluation of Gliclazide loaded Nanosuspension for Dissolution Rate Enhancement
Padmnabh, DC Bhatt
Diabetes mellitus is a prolonged metabolic condition categorized through elevated blood glucose levels. To treat this condition, oral antihyperglycemic medications like gliclazide, a second-generation sulfonylurea insulin secretagogue, are commonly used. Gliclazide comes into the biopharmaceutical classification system (BCS) class-II types, known for its lower solubility. To enhance its solubility, gliclazide was integrated into nanosuspensions. This study focused on formulating these gliclazide nanosuspensions using Kollicoat IR and Soluplus through the anti-solvent-precipitation method, through optimization achieved using the Box Behnken Design. Key parameters assessed included particle size (224 ± 1.23 nm) and entrapment efficiency (95.65 ± 0.12%). The drug release studies conducted on pH 7.4 indicated that over 95% of the drug was released within 30 minutes for the nanosuspension, whereas the pure drug solution released less than 70% in the same time frame, indicating immediate release with the nanosuspension. The morphology was examined using scanning electron microscopy (SEM), while fourier transform infrared (FTIR), X-Ray diffractometers (XRD), and differential scanning calorimeter (DSC) analyses confirmed the presence of the drug within the nanosuspension. In summary, the incorporation of gliclazide into nanosuspensions proved successful, resulting in enhanced release characteristics and ameliorated solubility.

46. Response Surface Methodology Assisted RP-HPLC Method for the Determination of Meropenem in Human Plasma: Application to a Pharmacokinetic Study
Jyothikrishna P, Anoop Karthika, Krishnaveni Nagappan, Deepalakshmi M, Arun KP
A simple, accurate and precise development of an reversed-phase high-performance liquid chromatography (RP-HPLC) method for the quantification of meropenem in human plasma samples for therapeutic drug monitoring (TDM) was developed and validated after optimization of various chromatographic parameters. The best recovery of meropenem was achieved through sample preparation based on a simple extraction method that included deproteinization and extraction with acetonitrile. The developed method reported acceptable values for selectivity, linearity, accuracy and precision, carry-over, dilution integrity and stability. The developed method was efficiently shown to be applicable to a real-time monitoring and pharmacokinetic study of meropenem in critically ill patients.

47. Synthesizing Radiological Insights: Enhancing Lung Disease Classification through Multimodal Imaging
CS Kumari, K Seethalakshmi
Precisely categorizing lung diseases is essential for effective medical treatments. This paper presents a comprehensive analysis of advanced methods in lung disease classification, with a focus on integrating diverse imaging techniques like computerized tomography (CT), X-rays, and magnetic resonance imaging (MRI). These imaging approaches collectively enhance the understanding of pulmonary conditions, aiding in early detection and differential diagnosis. The paper initially explains the fundamental principles of CT, MRI, and X-rays, highlighting their unique characteristics and roles in elucidating lung structures. It explores state-of-the-art methodologies, encompassing both traditional machine learning using engineered features and the expanding domain of deep learning utilizing neural networks to classify intricate diseases. A wide range of prevalent lung ailments, spanning from pneumonia and lung cancer to chronic obstructive pulmonary disease (COPD), are covered. Each domain delves into the considerations for adapting imaging modalities, involving data pre-processing, feature extraction, and algorithmic orchestration. Comparative evaluations of performance metrics offer insights into the effectiveness and limitations of each approach. Furthermore, the paper outlines the challenges associated with classifying lung diseases, including limited annotated data, complexities in model interpretation, and the seamless integration of algorithmic outcomes into clinical practices. As for future research avenues, the paper suggests innovative directions such as data augmentation, integrating multi-modal imaging information, and advancing transparent artificial intelligence (AI) frameworks to enhance their acceptance in clinical settings.

48. Assessing Medicinal Plant Extracts in Strengthening Anti-Dandruff Shampoo: An Analysis Using Multi-Criteria Decision-Making Techniques
Vibha Tiwari, Sarla More, Suman Gulia, Sunder Selwyn T, M Ramachandran
Currently, more than half of the global population grapples with dandruff. The presence of the Malassezia fungus significantly contributes to this condition by potentially triggering the production of cytokines in keratinocytes, the cells responsible for synthesizing keratin and activating inflammatory pathways. Given the distress caused by dandruff, considerable efforts are underway to find effective treatments. Numerous studies centered on medicinal plants suggest promising efficacy in addressing this issue. This particular research focuses on conducting a clinical trial to explore the effectiveness of zinc L-pyrrolidone carboxylic acid and pirocton olamine, combined with extracts from six medicinal plants, for dandruff therapy. In this study, a combination of methanolic extracts from alternatives, along with pirocton olamine and zinc-PCA in the form of shampoo, was applied to a group of 30 individuals experiencing dandruff. This treatment regimen was carried out over a span of two months to assess its effectiveness in managing dandruff. Notably, 15 patients with persistent dandruff experienced significant relief within the initial two weeks. Another 12 patients noticed dandruff reduction after 28 days, the majority experienced relief within the first few weeks, and by the end of the fifth week, those remaining also expressed satisfaction with the treatment. These results strongly highlight the impressive effectiveness of medicinal plant extracts in alleviating dandruff, accompanied by minimal side effects, albeit requiring extended treatment duration. The research indicates that blending medicinal plant extracts with both natural and chemical compounds in pharmaceutical formulations shows potential for enhancing the effectiveness of dandruff treatments.

49. Synergistic Antifungal Bioassay of Neem Leaves Extract with Essential Oils against Dermatophytes
Rupali Tiple, Shamli Jamane, Deepak Khobragade, Shital Sharma
Introduction: The neem plant is also known as a panacea in dentistry due to its antimicrobial properties and plays vital role in the cosmetic industry as it is extensively used in cosmetic preparations for hair and skin care. Objective: The present study was carried out to evaluate the synergistic activity of essential oils in combination with neem leaves ethanolic extracts. Methods: The antifungal activity of neem leaves (Azadirachta indica) ethanolic extracts in combination with Azadirachta indica, Eucalyptus citriodora and Cymbopogon martini essential oils was conducted by agar well diffusion method followed by M38-A2 broth microdilution method on pathogenic dermatophytes strains; Microsporum gypseum, Trichophyton mentagrophytes and T. rubrum. Neem leaves extract was obtained by treating the matured green leaves with ethanol. Moreover, HPLC analysis was performed to narrate the terpenoid content having extensively noted antifungal spectrum. The potent antimycotic fluconazole taken as a positive control. Result: The result exhibited that there was overall growth retardation of the dermatophytes at minimum inhibitory concentration between 125 to 250 μg/mL for leaves extract and between 0.078 to 5.0 μL for selected essential oils. The range of Minimum Inhibitory Concentration (MIC) of fluconazole was found between 0.25 and 0.50 μg/mL. Conclusion: Neem leaves ethanolic extracts analysis showed the possible existence of terpenoids in extracts that are recognized having extensive biological action. The outcomes of this study showed a novel report on the therapeutic potential of neem leaves extract with A. indica, E. citriodora and C. martini to control dermatophytosis. The neem leaf extract and antifungal herbal oil in combination have been proven to improve and broad-spectrum antifungal activity and they can be formulated in suitable formulations for the effective treatment of mycosis.

50. Computational Identification of Methionyl-tRNA-Synthetase Inhibitors for Brucella melitensis: A Hybrid of Ligand-based Classic 3-Point Pharmacophore Screening and Structure Cavity Guided Blind Docking Approach
Sumit Deore, Ramanlal Kachave, Pranjal Gholap, Kiran Mahajan, Harshal Tare
This study employs a hybrid computational approach to identify potential methionyl-tRNA synthetase inhibitors for Brucella melitensis. Utilizing ligand-based pharmacophore screening and structure-based blind docking, we selected a lead compound, CHEMBL349379, from the ChEMBL 2D database. Docking simulations revealed high binding affinity and favorable interactions. Lead optimization using ADMETlab 2.0 demonstrated promising drug-like properties, but a detailed toxicity analysis highlighted concerns. Experimental validation is needed to confirm inhibitory potential and address toxicity issues. This approach streamlines the identification of potential therapeutic agents for B. melitensis treatment.

51. RP-HPLC Method for the Simultaneous Determination of Sofosbuvir and Daclatasvir in Pure and Pharmaceutical Dosage Forms
Amol Badkhal, Prachi Verma, Sandip Umare, Vishal Patond, Dhirendra Sanghai, Priti Chincholkar
Daclatasvir and sofosbuvir in pure and medicinal dosage forms can be determined quickly and easily using a reversed-phase high-performance liquid chromatography (RP-HPLC) technique. An accurate, reproducible method was developed and validated. The mobile phase contained a mixture of 90% methanol:10% water (0.05% OPA). UV estimation was done with a flow rate of 0.7 mL/min and wavelength of 275 nm. The temperature was 30°C. Sofosbuvir stays in the body for3.361 minutes and daclatasvir for 5.745 minutes. A quantitative study of commercial dosage forms went well with this method, which was made and tested. Sofosbuvir and daclatasvir each had a %RSD of 0.43 and 0.28, respectively. Recoveries were 97.85 and 98.52% for sofosbuvir and daclatasvir, respectively. Three methods were checked for precision, accuracy, linearity, selectivity, specificity, limit of detection (LoD), limit of quantitation (LoQ), robustness, and ruggedness according to rules of the International Council for Harmonisation (ICH).

52. A Comparative Study between Butorphanol and Fentanyl as an Analgesic in Patients Undergoing Abdominal Surgeries under General Anesthesia
V Premkumar, Shiladitya Bose, Arun K B, R Brindha
Background: Narcotic analgesics are frequently utilized during epidural anesthesia in addition to local anesthetics (LA). However, the parent drug, morphine, had a long latency and was poorly soluble in lipids when it was first used for epidural analgesia. Fentanyl and butorphanol have not been compared in any research as supplements for intraoperative epidural anesthesia. For lower abdominal surgery, the current study compared the effectiveness and safety of epidural fentanyl versus epidural butorphanol. Materials and Methods: Patients undergoing abdominal surgery in the Department of Anesthesiology at a Tertiary Care Teaching institute in Tamil Nadu participated in a hospital-based randomized clinical study. All of the patients in the Department of Anesthesiology who had elective abdominal surgery were included in the 15-month research. The patients were split into two groups: Group A received an intravenous dose of 40 μg/kg butorphanol, whereas group B received an intravenous dose of 2 μg/kg fentanyl. Results: There were 100 participants in all, with men making up the majority (57.0%) and having a M:F ratio of 1.3:1. The participants in the study were 46.9 ± 6.8 years old on average. Conclusion: Butorphanol is found to be a better analgesic when compared to fentanyl, along with cardio-stability and fewer complications.

52. Concurrent Estimation of a Three Combination Type-2 Anti-diabetic Oral Dosage Form by Ultra-performance Liquid Chromatography
Rajya L Nimmagadda, Sowjanya Gummadi
Estimation of a three-combination dosage form containing metformin (MET), vildagliptin (VLDG), and remogliflozin etabonate (REMET) was performed by developing an economically simple and isocratic simultaneous method using ultra-performance liquid chromatograph (Alliance 1100 series) comprising of X-Bridge (50 × 4.6 mm, 2.5 μ) C18 column and photo diode array detector. 0.1 % v/v trifluoro acetic acid: acetonitrile (60:40% v/v) movable phase at 0.5 mL/min was used. The analytes were detected at a wavelength of 240.0 nm at 8.0 min. run time. The respective retention times of 1.004, 2.005, 5.118 min. was achieved concurrently for metformin, vildagliptin, and remogliflozin etabonate. The method was validated for various parameters according to international council for harmonization. Linearity was established at 187.50 to 1125.00 μg/mL (R2 = 0.9997), 18.75 to 112.50 μg/mL (R2 = 0.9990), 37.50 – 225.00 μg/ mL (R2 = 0.9997). The respective limit of detection and quantification were 22.50; 75.0 (MET) 2.25; 7.5 (VLDG) and 4.50; 15.0 μg/mL (REM ET). A recovery (% w/w) of 99.0 ± 1 % was obtained for metformin, vildagliptin, and remogliflozin etabonate, respectively. Various degradation studies were conducted and degradants were identified at different retention times.

54. A Novel Stability Indicating RP-HPLC with PDA Approach for Estimation of Voclosporin in Bulk and Marketed Formulation
Krishnaphanisri Ponnekanti, Ramreddy Godela, Anusha Addanki, Dimpu SV Doddi, Deepika B Burjukindi, Harish Dolla, Nagavamshi Gunnala
An easy, specific, and reliable method for determining voclosporin has been established using the reversed phase-high performance liquid chromatography (RP-HPLC) approach. Chromatographic conditions included stationary phase C18 Kromasil (250 mm x 4.6 mm and 5 μm), solvent system (0.1% OPA: Acetonitrile) in a 60:40 ratio, 1-mL/min flow rate, and detection wavelength of 282 nm were opted to separate the voclosporin with retention time of 2.2 minutes. A linearity analysis was performed between 3.95 to 23.7 μg/mL, and the R2 value was found to be 0.999. Precision’s %RSD was determined to be between 0.4 and 0.7. The limit of detection (LoD) and limit of quantitation (LoQ) values are 0.01 and 0.03 μg/mL, respectively. Using the aforesaid approach, the %assay of the marketed formulation was 99.07%. To test the stability representing characteristics of the suggested approach, forced degradation experiments of voclosporin were performed and %degradation was measured. Because the procedure was easy, precise, accurate, and cost-effective, it may be poted for regular analysis of quality control samples in industry.

55. In-silico Study of Epicathecin from Cinnamomum verum Against Insulin Receptor for Diabetes Mellitus
Brahma S R Desu, Vikas Kumar, Anitha L, Shaik Kareemulla, Shakkeela Y E Ahammed, Sudhahar Dharmalingam, Hitesh H Mehta
Obesity has become more common in recent years. Fatalism can raise the chance of fatal metabolic and cardiovascular diseases. Type 2 diabetes is one of the metabolic illnesses brought on by fat. Insulin receptor resistance, also known as non-insulin dependent type 2 diabetes, is a consequence of type 2 diabetes. Reduced insulin sensitivity and the inability of pancreatic beta cells to produce enough insulin to offset the development of resistance are the main causes of type 2 diabetes mellitus. Insulin receptor problems that decrease INSR expression on the cell surface and follow receptor abnormalities are the common mechanisms behind insulin receptor resistance. The single-nucleotide found in INSR. Increasing the expression of 4IBM is one strategy to combat its effects on insulin receptor function and increased risk of INSR-mediated illnesses. Based on earlier studies, cinnamon (Cinnamomum verum), a traditional plant, has been shown to have potential as a treatment for a number of illnesses, including diabetes mellitus. Using Autodock 4 and the Lamarckian genetic algorithm as a basis, this in-silico study intends to investigate the potential of active compounds found in cinnamon and their role as 4IBM protein inhibitors for therapy in type 2 diabetes mellitus. The binding energy ranged from -7.95 to -6.15 kcal/mol, according to docking data, with the compound epicatechin having the lowest binding energy and an inhibitory constant of 7.80. Further investigation into the active ingredients in cinnamon and their potential use in the treatment of diabetes mellitus can be based on the findings of this study.

56. Development of Novel RP-HPLC Method for Estimating Tepotinib in Bulk and Pharmaceutical Dosage Form
Smita T Kumbhar, Pratima S Kokare, Pradip B Digge
Objective: The study’s goal is to develop a highly appropriate, fast, precise, and validated reverse-phase high-performance liquid chromatography (RP-HPLC) approach that indicates stability for the estimation of tepotinib in pharmaceutical dosage form and bulk, in accordance with ICH recommendations. Method: The components were separated by chromatography using a Phenomenex Kinetex XB-C18 (150×4.6 mm, 5μ) column. The absorbance was measured at 272 nm, and the flow rate was 1.0 mL̸min. The International Council for Harmonisation (ICH) states that checks were made for linearity, precision, accuracy, system appropriateness, specificity, and protocol robustness. Results: Tepotinib was shown to have a retention period of 3.4 minutes. The results showed that the linearity ranged from 5 to 25 μg/mL (r2 = 0.9993), and the percentage mean recoveries for tepotinib’s accuracy and precision fell within the range of (%RSD˂ 2). It was discovered that the Limit of Detection (LoD), and Limit of Quantitation (LoQ) were, respectively, 0.429 and 1.3 μg/mL.

57. Validated First-Order Derivative Ultraviolet Spectrophotometric Determination of Rebamipide in Pharmaceutical Products
Karajgi S R, Madabhavi S, Chetan M, Potadar S S
A very simple, accurate, precise, and reproducible process has been established for the estimation of rebamipide in pharmaceuticals. The literature review suggested that no UV method for quantitative estimation of first-order derivative for the rebamipide, accordingly a method has been developed and reported. As per the need for design a novel approach to analyze the drug utilizing dimethyl formamide as a solvent was identified. Rebamipide has absorbance maxima for first order derivative 314 nm. Rebamipide drug follows Beer’s law in a range of concentration between 20 to 200 μg/mL. The recovery studies verified the proposed method’s accuracy and findings were validated in accordance with ICH recommendations. The findings were deemed to be reliable and satisfactory. As a result, the suggested method can be used to quantitatively estimate Rebamipide in ordinary analysis work.

58. Development and Validation of UPLC-MS/MS Bioanalytical Method for Simultaneous Quantification of the Antiretroviral Drugs Dolutegravir, Lamivudine, and Tenofovir in Human Plasma
Veerareddy Vyshali, Kumaraswamy Gandla
The current proposed validated bio-analytical UPLC-MS/MS method for assessing components like dolutegravir, lamivudine, and tenofovir in human plasma using bictigravir as an internal standard with a mobile phase of formic acid (0.1%), 2 Mm ammonium formate in water and acetonitrile (30:70, v/v), and optimized flow rate of 0.5 mL/min, the separation was performed on an Agilent XDB C18 column (250 mm X 4.6, 5μ). The three components were analyzed by using LC-MS/MS in positive ion mode owing to the presence of primary groups. For the technique validation for the concentration range of 20 to 1000ng/mLfor dolutegravir, lamivudine, and tenofovir in human plasma, bitigravir was employed as the internal control. The three-drug moieties average recoveries from spiking plasma samples were discovered to be reproducible. Based on the data displayed above, it was determined that the procedure was rapid and dependable, with a minimum total run duration of 3.0 minutes. The stability studies were assessed as a consequence of the current approach’s successful validation in accordance with the food and drug administration (FDA), european medicines agency (EMA), and international council for harmonisation (ICH) requirements.

59. Practice on Antibiotic Use: Analysis of Overall Practice Score in Indian Set-up
Mayur H Ingale, Vinod Shinde, Apurva Jharandikar, Motilal Tayade, G D Mahajan
Antibiotic resistance poses a significant global health threat, necessitating a detailed analysis of antibiotic use practices in diverse healthcare environments. This study, situated in the Indian context, scrutinizes the overall practice scores associated with antibiotic utilization. In part VI of our research series, we explore intricate patterns and factors influencing antibiotic prescription, dispensation, and adherence to guidelines within Indian healthcare setups. The findings reveal multifaceted challenges faced by healthcare practitioners, encompassing issues of over prescription, inadequate awareness among patients, and varying adherence to established protocols. By employing a comprehensive approach, this study sheds light on the nuanced intricacies of antibiotic use practices, allowing for a nuanced understanding of the Indian healthcare landscape. The insights garnered in this research can inform targeted interventions, policy formulation, and educational initiatives, aiming to enhance antibiotic stewardship in Indian healthcare settings. As the world grapples with antibiotic resistance, this analysis provides valuable perspectives essential for effective and sustainable strategies in mitigating this pressing global health concern.

60. Exploring the Therapeutic Potential of Azadirachta indica (Neem): Recent Advances and Applications
Suresh Dhakar, Sachin K Jain, Harshal Tare
This review explains the therapeutic prospective of Azadirachta indica (Neem), a traditional medicinal tree in India, Southeast Asia, and Africa. Neem extracts have been found to have various therapeutic properties, including antimicrobial, antifungal, hepatoprotective, antiulcer, antifertility, and antinociceptive properties. Recent research has shown neem’s potential as an antiviral agent, cancer treatment, and a source of antibiotic compounds. Neem oil nano hydrogel shows significant antimicrobial activity against various pathogens. The plant also has the potential to mitigate heavy metal pollution and develop a model for predicting soil remediation using neem leaves. Neem’s inhibitory activity on papain-like protease of SARS-CoV-2 is also explored. Overall, neem’s therapeutic potential is significant and its potential in healthcare and environmental remediation is highlighted.

61. A Review of the Psychological Aspects of Childhood Obesity: Causes, Consequences and Treatment
Vrushabh Hupparage, Tanaya Waman, Pradnya Waman, Pooja Yadav, Harshal Tare, Ganesh Dama
The psychological and social effects of the worldwide epidemic of childhood obesity are widespread. Psychosocial factors may play role in childhood fatness, and this has piqued the curiosity of researchers. Childhood obesity is connected through psychological and social consequences such as physical inactivity, negative social interactions, stress, depression and anxiety and lower self-esteem and symptoms of psychiatric dysfunction. The purpose of this review was to broaden knowledge of childhood obesity-related treatment, causes, and consequences. This article also elaborates the evidence-based diagnosis, current treatment involves dietary management, psychosocial involvement, behavioral modification and some traditional medicine used for the treatment of obesity.

62. Carbon Quantum Dots: Properties, Synthetic Methods, Applications in Pharmaceutical and Pollutant Analysis
Surendra Agrawal, Pravina Gurjar, Saraswathy Nagendran
Introduction: The nanostructured form of carbon known as carbon quantum dots has shown promise in a wide range of fields, including bioimaging, optoelectronics, bio-sensing drug delivery systems, photovoltaics, and photocatalysis. They stand out from the crowd thanks to exceptional conductivity, low toxicity, and great photochemical and thermal stability. Objectives: This article provides a concise overview of the last decade’s worth of study into the use of carbon quantum dots (QDs) like CDs, GQDs, and PDs in the creation of a fluorescence imaging bio-sensing system for the early detection of cancer. Methods: Recent research in the field of Carbon QD (CQD) in the last 20 years was collected, sorted for their application in analysis and summarized. Results and conclusion: Most recent research on the CQDs has focused on their fluorescence characteristics and photocatalytic properties. The authors offer a glimpse into the future in an effort to help researchers overcome obstacles and dive further into this exciting topic.

63. An Inquiry into the Role of Muscle Atrophy in Rheumatoid Arthritis and Current Treatment Scenario
Prasanna Phutane, Gaurav Mude, Pranali Shastrakar
Around the world, 0.5 to 1% of adults suffer from rheumatoid arthritis. It is a chronic autoimmune inflammatory illness distinguished by inflammation of hands, knees, wrists, and feet, causing bone and cartilage degradation, joint deformity, and muscle atrophy and thus movement limitations. Inflammatory mediators like necrosis factor and interleukins along with other inflammatory cytokines, execute a vital role in the initiation and advancement of rheumatoid arthritis (RA) as well as muscle atrophy. Existing literature discusses extensively the RA condition. However, the muscle atrophy related to this condition has received little attention, despite the substantial role of muscle atrophy in morbidity caused by RA. The review aims to highlight the relationship between muscle atrophy and RA, the mechanisms of muscle atrophy in RA and the association between oxidative stress and muscle atrophy in RA. This review will be useful for getting insights into the etiopathogenesis of muscle atrophy brought on by rheumatoid arthritis and available treatment alternatives for RA and muscle atrophy caused by RA. Discussion on the potential therapeutic targets and agents to treat skeletal muscle atrophy will help advance the knowledge to improve the condition of muscle atrophy associated with RA.

64. A Methodical Review on Allergens and Allergic Reactions
Hemalata Dange, Rupali Patil, Chandrasekhar Upasani
Allergic reactions can lead to a variety of symptoms, like rhinorrhoea, nasal congestion, and sneezing; eye and ear irritation, too few apparent symptoms include throat problems, cough, asthma and breathlessness and eczema. The major side effect of older antihistamines is drowsiness. Recent antihistamines normally do not cause drowsiness. Human develops hypersensitivity as a result of their immune system being overactive. Gamma globulins are created in excess during an allergic reaction. Normally, the purpose of these gamma globulins is to combat microbial infections. IgE gamma globulin functions abnormally in case of allergic onset. Various allergens (pollens, animal dander) are considered as a foreign material. IgE try to “destroy” the allergens. A series of chemical reactions take place when IgE attaches to the allergens which involves the release of histamine into the body from mast cells and results in various allergic symptoms. In this review, various allergic causes, symptoms, allergens, and treatments for allergic reactions are summarized.

65. Nanosponges- A Versatile Approach of Drug Delivery System
Alka Singh, Chetan S Chauhan
With the escalating number of diseases, an opportunistic target drug delivery system is needed. Nanosponges (NS) are nanosized drug delivery systems having three-dimensional (3D) configurations, fabricated by crosslinking of polymers to ensnare a wide assortment of drugs. These small particles move inside the body till they arrive at the target site and deliver the medication in a specific and controlled way. They can ensnare (entrap) both hydrophilic and hydrophobic moieties in a smarter manner and improve the solubility and bioavailability of drugs. NS have been utilized to examine the medication conveyance by oral, parenteral, and topical routes. Another significant property of NS is that they can work on the solvency of ineffectively water-soluble moieties and are utilized for the storage of gases, and proteins as well as for the removal of toxins from the systemic circulation. The present review highlights the types of nanosponges, their methods of preparation, characterization, and applications in drug delivery.

66. Gastro Retentive Drug Delivery System: Latest Approach towards Novel Drug Delivery
Devi Prasad, Tarun Parashar, Shivansh Khaudiyal, Akanksha Semwal, Vikash Jakhmola
Various efforts have been undertaken to enhance the bioavailability and clinical performance of oral drug formulations. In pursuit of improving the therapeutic effectiveness of medications that are susceptible to degradation in alkaline pH environments, possess a limited window for absorption within the stomach, and readily dissolve under acidic conditions, a diverse range of gastro-retentive drug delivery systems (GRDDS) have been innovatively designed and developed. As a result, the stomach’s physiological state and the various factors that influence GRDDS will be discussed. As a rule, this survey will enlighten and coordinate enumerating scientists in arranging, plan, and planning the GRDDS.

67. A Review of Botanical Aspects and Various Pharmacological Actions of Bergamot (Citrus bergamia) Essential Oil
Pranali Shastrakar, Kunal Kotkar, Manish Gagarani, Surendra Agrawal
In this review article, there is a brief about Bergamot essential oil, this article tells about the descriptive information about botanical aspects, significance and characteristics, anatomy, chemistry, its pharmacological activity, and toxicology of Bergamot essential oil. Citrus bergamia Risso, a combination of Citrus limon L and Citrus aurantium is the scientific name for the citrus fruit known as bergamot. It belongs to the family Rutaceae and the genus Citrus. BEO shows different type of pharmacological activity like anti-anxiety, wound healing, neuroprotective, anti-depressant, antiproliferative, antibacterial, anticancer, antioxidant, anti-inflammatory and antinociceptive, anti-mycoplasmal, anti-fungal andAntiallodynic. BEO contains various volatile and non-volatile fractions.

68. Spinal Muscular Atrophy, Approved Therapies and Future Prospects
Sushrut Kamle, Saurabh Sharma, Prasanna Phutane
Spinal muscular atrophy (SMA) is a complex congenital myoneural disorder, noted for gradual muscle atrophy leading to increasing muscular weakness and significant disability. SMA manifests broad array of clinical severity and its clinical traits can be graded into four primary phenotypes -SMA type I, II, III and IV mainly based on the age of onset of symptoms and highest motor milestones attained. Over the past few years, numerous feasible interventions found on the commonly accepted precept of augmenting the translation of the survival motor neuron (SMN) protein have been tried. Gene therapies focusing on SMN include splicing modulation of SMN2 gene (nusinersen) and replacing SMN1 gene (onasemnogene abeparvovec), whereas therapies focusing SMN-independent factors involve treatments improving muscular function, treatment of spinal deformities and neuroprotection. A noted milestone in history of SMA was the approval of Nusinersen in 2016. It was followed by approval in 2019 and in 2020 to onasemnogene abeparvovec and risdiplam respectively. These three approved therapies offered hope to the patients and their families globally. But some of the weaknesses are also associated with these therapies. Deficiency of phase 4 clinical trial data, high price tag, nonavailability of guidelines for the selection of therapies for specific phenotypes and lack of data form clinical trial targeted to compare safety and efficacy of currently approved therapies are some of the issues that licensed therapies for SMA are suffering. In the face such challenges, initiation of intervention at an early age along with the utilization of adjunct therapies seems to be a sound approach to treat SMA patients. The review discusses the classification, clinical description, genetics, diagnostics and treatment of SMA along with SMN independent therapeutic targets that can utilised for the development of new therapies.

69. Exploring the Multifaceted Potential of Annona squamosa: a Natural Treasure for Health and Wellness
Suresh Dhakar, Sachin K Jain, Harshal Tare
This article gives an in-depth look at the tropical fruit Annona squamosa L., which has a long history of traditional medicinal usage and is discussed in this review for its phytochemical and pharmacological qualities. The botanical specimen showcases an extensive assortment of bioactive constituents, encompassing glycosides, proteins, carbohydrates, saponins, alkaloids, flavonoids, and phenolics, which have significant antioxidant, antibacterial, antiviral, anticancer, antidiabetic, anti-inflammatory, anti-ulcer, and skin-protective properties. The leaves contain high protein content and essential oils amusing in terpenes and sesquiterpenes, which have shown potential in treating health conditions.

70. Exploring the Therapeutic Potential of Allium sativum: Recent Advances and Applications
Suresh Dhakar, Harshal Tare, Sachin K Jain
This review dives into the multidimensional character of Allium sativum, generally known as garlic, exploring its botanical aspects, chemical elements, and varied pharmacological effects. With a complex array of sulfur compounds, amino acids, enzymes, and minerals, garlic has long been renowned for its strong flavor and therapeutic potential. Allicin and its derivatives are the focus of this research as it investigates the medical uses of garlic’s numerous sulfur compounds. Garlic has a wide variety of biomolecules, and this article investigates their potential synergistic effects on health to highlight the need for additional study in this field. Garlic’s pharmacological actions are also described in detail, providing insight into its prospective therapeutic applications. These activities range from its antiatherosclerotic and antihypertensive qualities to its anticancer, immunomodulatory, antifungal, and digestive effects.

71. Neurobiological Investigation of Depression: Unraveling the Biological Basis of a Complex Mental Health Challenge
Archana Panigrahy, Shakti Ketan Prusty, Ghanshyam Panigrahi
Individual depressive theories founded on neurobiological information are examined because they hold great relevance to both clinical investigators seeking to create innovative treatments for depression and physicians in everyday practice. One such theory is the proposition that the main underlying issue behind depressive disorders is a deficiency in central monoaminergic function. This theory highlights the importance of addressing the role of neurotransmitters such as glutamate, gamma-aminobutyric acid (GABA), norepinephrine, serotonin, and dopamine, as well as factors like neurocircuitry, neurotrophic factors, and the rhythm of the circadian clock. Major depressive disorder, a severe condition with significant societal and therapeutic implications, necessitates tailored antidepressant treatments. These treatments encompass both pharmacological interventions and emotional therapies, all of which need to be customized based on specific patients and medical circumstances. The understanding of depression is complex and constantly evolving, with various explanations and theories applying only to specific types of depressed individuals while disregarding others. Furthermore, the pathogenesis of depression can undergo significant changes during the disease’s development. This dynamic nature challenges the notion that depression can be characterized by a single hypothesis or theory. Thus, the extensive body of available research highlights the need for a comprehensive approach that incorporates multiple concepts and factors when studying and treating depression. By considering the intricate interplay of various neurobiological elements and personal circumstances, researchers and medical professionals can strive to provide more effective and tailored interventions for individuals suffering from depression.

72. An Overview on Nitrogen-containing Heterocyclic Compounds as Anticancer Agents
Anshu R Dudhe, Sachinkumar D Gunjal, Sampath AG, Sushama Rawat, YY Nandurkar
Cancer accounts for nearly 10 million losses each year. Among the most prevalent cancer types are breast, lung, colon, rectum, and prostate cancers. Astonishingly, around one-third of cancer-related deaths can be attributed to factors such as tobacco usage, a high body mass index (BMI), alcohol consumption, restricted ingestion of fruits and vegetables, and inadequate bodily bustle. In the field of pharmaceuticals, heteroatoms and heterocyclic compounds frequently assume crucial roles and serve as common structural components in numerous active natural products. Statistically, the majority of biologically active compounds is either heterocycles themselves or incorporate a heterocyclic element, with nitrogen-containing heterocycles being the most prevalent structural framework in these intricate molecules. These findings underscore the significant and ever-evolving role of heterocycles in contemporary drug blueprints and drug sighting practice. The chief hub of the review was to explore the documented anti-cancer properties of nitrogen-containing heterocyclic compounds, as reported in current scientific literature.

73. Role of the National Control Laboratories in Ensuring the Quality, Safety and Efficacy of Blood Products in India
Tara Chand, Manoj Kumar, Brij Bhushan, Anoop Kumar, Apoorva A Talwar, Varun Singh, Girija LV, Tanya Maheriya, Shiksha Rani, Manvandra P Singh, Harish Chander, Anup Anvikar, Meena Kumari
National control laboratories (NCLs) are responsible for testing of the batches of drugs prior to their release on the market. NCLs play an important role in strengthening a country’s regulatory systems. The National Institute of Biologicals is an NCL in India for the testing and coenzyme A (CoA) release of biologicals such as biotherapeutics, vaccines, and diagnostic medical devices. Every year, the National Institute of Biologicals tests and CoA releases thousands of batches of blood products following compendial specifications and schedule F, part XII-C (G) of Drugs and Cosmetics Rules 1945. This institute also participates in collaborative studies with the WHO for the establishment of international reference standards. In the last thirteen years (2010–2022), the blood products laboratory at this institute has evaluated 5159 batches of blood products, and 95 batches (1.84%) were declared as not of standard quality. As per CDSCO “the ‘not of standard’ quality products are categorized into three categories: A, B and C”. These 95 batches include all three categories (A, B and C) of “not of standard” quality blood products.

74. Exploring the Role of Phytochemicals in Arthritic Disorders: A Review
Rahul Trivedi, Rajesh B Hadia, Sunil Kardani, Rajesh A Maheshwari
Rheumatoid arthritis (RA) is a prevalent inflammatory condition exemplified by a prolonged course and diverse levels of complexity in symptoms involving joints, extra-articular organs and systemic manifestations, impacting a substantial number of people worldwide. The current treatment regimen of RA involves various synthetic drugs which cause severe side effects and occasionally infections also having high cost and impaired life quality. Plants and herbs contain abundant phytochemicals, which have demonstrated effectiveness in preventing, treating, or alleviating a range of health issues. Phytochemicals due to their low cost, safety and effectiveness in RA treatment and better patient acceptability are used as an alternative therapy. Currently, varied phytochemicals are isolated and evaluated for anti-arthritic drugs as they possess diverse chemical structures and specific biological actions. Phytochemicals are tested as a novel curative approach for arthritis management. In the present review, our intention is to present the role of different phytochemicals in reducing the progression of RA. We also aim to present a mechanism-based reduction of arthritic symptoms.

75. Impact of Counseling on Patient Education and Dietary in Quality of Lifestyle and Nutritional Anemia in Diabetes Mellitus Patient: A Case-Control Study
Shweta Bhandari, Vishal Garg, Sumeet Dwivedi
The study’s goal was to see how w education and dietary guidance improved the quality of lifestyle and nutritional anemia in people with diabetes type 2. This 6 month prospective study was conducted in a hospital in Jaipur, Rajasthan. The demographic information (age, gender, social position, and economic status) was gathered using a form HRQoL after gaining the patient’s assent. In the intervention group n is 21 and also in the control group n is 21 so the total; patient was chosen 42. The baseline Hb and health-related quality score were taken in consideration in 1, 2 and baseline visits in a month-long study as a part of the design. Each visit concluded with the measurement of the hemoglobin level and health-related quality of life scores for both the intervention and control groups. The intervention group’s Hblevel changed significantly more than the control group’s after the nutrition education intervention finished [0.56–0.40 vs. 0.16–0.82 gm/dl, p = 0.002]. In contrast to the control group, where the mean increase in general health from baseline to second follow-up was statistically insignificant, the intervention group’s mean increase in general health from baseline to second follow-up was found to be significant as from the result obtained. Thus, nutrition education was found to be substantially linked to higher Hb levels, better dietary consumption, and improved health-related quality.

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