International Journal of

Pharmaceutical Quality Assurance

ISSN: 0975 9506
Peer Review Journal

doi prefix: 10.25258/ijpqa

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This journal is member of Crossref. 

1. Exploration of In-vitro Antidiabetic Activity of ZnO NPs and Ag NPs Synthesized using Methanolic Extracts of Alpinia mutica and Tradescantia spathaeca Leaves
Shankaraiah Pulipaka, Ashish Suttee, M. Ravi Kumar, Ramesh Kasarla
Diabetes might be cured with the use of medicinal herbs and environmentally friendly production of metallic nanoparticles (Ag NPs) and ZnO NPs. The methanolic leaf extracts of Alpinia mutica and Tradescantia spathaeca were used to synthesize silver nanoparticles (Ag NPs) and zinc oxide nanoparticles (ZnO NPs), respectively, for in-vitro evaluation.
Methanolic leaf extracts of A. mutica and T. spathaeca were used to create AgNPs and ZnO NPs under ambient conditions using ultrasound-assisted extraction (UAE). Their ability to block alpha- and beta-amylase confirmed the in-vitro antidiabetic efficacy of methanolic leaf extract of plant (MLEP), AgNPs, and ZnO NPs. In this study, α- amylase activity of ZnO and nanoparticles of silver produced from natural sources will be evaluated in an effort to lessen the toxicity and negative effects of the inhibitor used to treat diabetes. Antidiabetic action was especially impressive in the ZnO and silver nanoparticles produced using methanolic extracts of A. mutica and T. spathaeca. Because of their promising in-vitro antidiabetic action with alpha-amylase activity, MLEP of A. mutica and T. spathaeca, AgNPs, and ZnO NPs show promise for future medical uses.

2. Synthesis and In-vivo Anticancer Evaluation of N-(4-oxo-2- (4-((5-aryl-1,3,4 thiadiazole-2yl) amino) Phenyl thiazolidine-3-yl) Benzamide derivative
Amit Chawla, Lalchand Devhare, G. Dharmamoorthy, Ritika, Sachin Tyagi
The development of novel antitumor agents is paramount in the fight against drug resistance and its associated cardiotoxicity. The present study carried out a thorough anticancer evaluation of N- (4-oxo-2-(4-((5-aryl-1,3,4 thiadiazole-2yl) amino) phenyl thiazolidine-3-yl) benzamide (TH08) in Ehrlich ascites carcinoma (EAC) in Swiss albino mice. Our assessment included the measurement of tumor weight, the duration of survival for mice with tumors, and tumor cell growth inhibition. Additionally, we analyzed hematological parameters, like white and red blood cells and hemoglobin levels. The results we obtained clearly demonstrate that TH08 is a potent anticancer agent that exerts a positive effect on EAC cells. To determine TH08’s effectiveness, We compared our findings to those achieved by using the standard medication, bleomycin. Our findings provide compelling evidence that TH08 has significant potential as a novel antitumor agent.

3. Synthesis, Characterisation, Molecular Docking Studies and Biological Evaluation of Novel Benzothiazole Derivatives as EGFR Inhibitors for Anti-breast Cancer Agents
Gnana R. Priya M, Lalchand D. Devhare, G. Dharmamoorthy, Mahendra V. Khairnar, R. Prasidha
Novel (2-anilino-N-(4,6-dimethyl-1,3-Benzosulfonazol-2-yl) ethanamide derivatives were synthesized and characterized by spectroscopy methods. All the compounds assessed for in-vitro antimicrobial activities on three strains are S. aureus, S. epidermis and E. coli by using disc plate method (25 μg/mL). Compounds 5a-5j showed good to excellent antimicrobial activity for three different strains compared to standard ciprofloxacin. Further screened by in-vitro cytotoxic activity against MCF-7 cell lines. Some compounds were 5i, 5c, 5b,5d and 5i showed high cytotoxic activities of IC50 values 73, 53,37,32 and 24 μg/mL, reference drug as Gefitinib against MCF-7 cell lines and MCF-12A. Further carried out docking studies using Schrodinger software to analyze the orientations, interactions and binding modes of these derivatives at the adenine -5-triphosphate binding site of EGFR (PDB ID: 2ITY), which indicated that the ligands show good interactions with active site residues in this structural benzothiazole class, and are considered lead compounds for further development as anti-breast cancer drugs.

4. Investigation of Antidiabetic Activity of Isolated Molecule from the Bark of Olax scandens
Johnsymary F, Komala M
Hyperglycemia caused by defects in insulin synthesis and/or activity characterizes diabetes mellitus (DM), which is categorized as a metabolic condition. Some patients may develop side effects or drug interactions when treating these disorders with synthetic drugs. Due to this, there is an increased interest in researching the medical properties of plants and herbal substances while also considering synthetic medications’ interactions and negative effects. To isolate and identify the flavonoid 5-hydroxy-apigenin-7-O-Dglucopyranoside, the bark of Olax scandens was extracted with methanol in a soxhlet system (5HAG). The current study set out to examine 5HAG’s potential ability to treat albino wistar rats with STZ-induced diabetes. The chemical component significantly lowered rats’ blood glucose levels and improved lipid markers. Hepatic enzymes improved significantly, including SGOT, SGPT, ALP, plasma insulin, and total proteins. Overall, this study exposes new avenues for researching how 5HAG reduces blood sugar levels so drastically, but according to the aforementioned study, the flavonoid possesses antidiabetic properties because of its antioxidant activity. In addition, the isolated flavonoid may significantly impact the reduction of blood sugar and its complications by acting as a lead molecule in the identification of novel antidiabetic drug candidates.

5. Development, Optimization, and Validation of a RP-HPLC Method with PDA Detection for the Concurrent Quantification of Emtricitabine, Tenofovir Alafenamide, and Dolutegravir in Both Bulk and Pharmaceutical Dosage Forms
Chandrudu J, Gandhimathi R
A simple, quick, precise and accurate HPLC (reverse phase) approach has been designed and optimized using a chemometric tool to estimate dolutegravir, emtricitabine and tenofovir alafenamide, respectively. A design of central composite was used to optimize the response surface. As a result of trial and error, the parameters such as rate of solvent flow, buffer pH, and methanol concentration in the solvent system were determined. System responsiveness was estimated using the optimization process’s capacity factor, resolution, and retention time. The separation was achieved by using a solvent system containing 58.90% methanol and 41.10 triethylamine buffer (4.56 pH) at the rate of flow of 0.8 mL per minute on a phenomenex carbon (18) column (150.4 4.6 mm; I.D., 5) under optimal conditions. The duration of retention for emtricitabine was 2.91 minutes, for tenofovir alafenamide it was 6.114 minutes; and for dolutegravir it was 8.824 minutes. A correlation coefficient of 0.9998, 0.9997, and 0.9999 was determined for emtricitabine’s calibration curves from 40 to 200 g/mL, tenofovir alafenamide’s from 5 to 25 g/mL, and emtricitabine’s from 10 to 50 g/mL, respectively. This approach was effective in estimating the simultaneous doses of medications in commercial combination forms.

6. The Effect of Selegiline on Reducing Oxidative Stress in Polymorphonuclear Blood Cells (Lymphocytes) Isolated from Patients with Rheumatoid Arthritis
Purbajit Chetia, Abdul B Ahmed
Rheumatoid arthritis (RA) is a persistent condition resulting in an inflammatory response abide by the pathological mechanism of autoimmunity that causes the cartilage, bone, and joint tissues to deteriorate, lowering one’s quality of life in general. Several studies have suggested a significant association between oxidative stress caused by leukocyte-mediated inflammatory responses and the conversion of a substantial amount of oxygen into diverse free radicals, resulting in oxidative harm, including the chronic nature of rheumatoid arthritis. The utilization of DMARDs which are known as biologic and conventional disease-modifying antirheumatic drugs, has exhibited encouraging results. However, it is crucial to prioritize the discovery of novel and efficacious medications for rheumatoid arthritis in order to address the constraints associated with current therapeutic approaches. Selegiline, a synthetic drug primarily employed to manage Parkinson’s disease, predominantly interferes with the MAO-B enzyme, also known as monoamine oxidase. Additionally, it has been demonstrated to possess free radical-neutralizing properties. The goal of this study is to assess the effectiveness of selegiline in reducing oxidative stress indicators in peripheral blood mononuclear lymphocyte cells isolated from individuals diagnosed with RA. Peripheral blood was collected from 20 RA patients in accordance with the American College of Rheumatology standard. Lymphocytes were isolated following incubation with 1.5 μg/mL phorbol myristate acetate (PMA) and treatment with different concentrations (50–200 μg/mL) of selegiline. This study reveals that selegiline in concentrations of 150 and 200 μg/mL was effective enough to alleviate oxidative stress by scavenging free radicals and improving the level of natural defensive enzymes playing as antioxidants. Therefore, it can be concluded that the MAO-B inhibitor selegiline has potential as a non-toxic repurposed medicine for curtailing the pathological effects of oxidative overload during RA, unlocking the opportunity for further investigation into the impact on other inflammatory cells, such as neutrophils.

7. Characterization of Degradation Products of Bisoprolol by LC-MS and In-silico Determination of Toxicity and Biological Activity Prediction of its Degradation Product: A Comprehensive Approach during Drug Development
Kavita Chandramore, Sandeep Sonawane
The stability of bisoprolol in tablet and bulk form was developed and validated using chromatographic methods. The bisoprolol was exposed to oxidizing agents like hydrogen peroxide, heat (dry and wet) and photolytic conditions, acid, alkali, and water hydrolysis. However, considerable degradation was observed in acid, alkali, oxidative, and wet heat thermal conditions. The drug’s stability under photolytic and dry heat conditions was established. The drug and its degradation products were separated on ODS C-18 with the specification of (250 mm × 4.6 mm, 5 μm) and the mobile phase containing acetonitrile and phosphate buffer (20 mM, pH 8) (60:40, v/v). According to ICH Q2 (R1) all method validation parameters are verified. Determination of the active pharmaceutical ingredient was not interfered by excipients or degradation products. In the 6–14 μg/mL range, the response was shown to be linear. One degradation product’s LC-MS m/z values and fragmentation patterns matched an impurity mentioned in the drug’s European Pharmacopoeia monograph. The remaining three were unidentified degradation products. LC-MS fragmentation experiments were used to characterize the products. The findings may lead to the suggestion of a more thorough drug degradation mechanism. The Toxtree software (Version 3.1.1) was then used to forecast the toxicity of the degradation products. Additional toxicity determination was carried out by using in-silico method.

8. An efficient RP-HPLC-PDA Method for Estimating Dolutegravir and Lamivudine in Combined Pharmaceutical Formulations using a Box-Behnken Design Approach
A. Ramyasree, S. Umadevi
This study used a quality-by-design (QbD) method to build a novel, high-performance reverse-phase fluid chromatography (RP-HPLC) system with diode array detection (DAD) for the simultaneous measurement of dolutegravir (DLG) and lamivudine (LMV) tablets. In accordance with the International Council for Harmonization’s (ICH) requirements, chromatographic conditions were adjusted utilizing the Box-Behnken design (BBD), and the resultant technique was verified for linearity, system appropriateness, precision, accuracy, sensitivity, robustness, and stability of the solution. At retention durations of 2,271 and 3,431 minutes, LMV and DLG peaks were separated using a C-18 column with 150 x 4.6 mm and 5 μm particles. The mobile phase was 0.1% orthophosphoric acid (OPA): acetonitrile (ACN) (50:50, v/v) at a flow rate of 0.8 mL/min and a pH of 3 at 25°C. Peaks were seen at 254 nm and the volume of sample injection was 20L. The percent strength of the commercially available tablet is 98.89 and 98.76 for LMV and DLG, respectively, using a standard calibration curve. The developed RP-HPLC technique’s stability is shown by the suggested RP-HPLC method’s capacity to identify LMV and DLG in the existence of their degradation products. As per ICH requirements, the findings of the validation parameters for linearity, system appropriateness, accuracy, precision, robustness, and sensitivity were all within acceptable limits. It is simple to use, accurate, efficient, and reasonably priced to employ the innovative RP-HPLC technology with BBD application for QbD.

9. Assessing the Impact of Temperature Management Interventions on Survival Outcomes in Adult Out-of-Hospital Cardiac Arrest: A Comprehensive Review of Randomized Controlled Trials
Ahmed M. Asiri, Salman A. Alzahrani, Afrah Y. Saddeek, Faisal A. Ghazwani, Abdulhakeem Alotaibi, Shahalil Alqani
A cardiac arrest patient who has recovered outside the hospital, managing body temperature is beneficial. There is still uncertainty as to what specific circumstances should be met in order for such interventions to be initiated. Researchers have used different methods to study OHCA TTM interventions due to the uncertainty surrounding their outcomes. The study’s main objective is to determine if temperature management affects survival outcomes in adult cardiac arrests occurring outside of the hospital. Several online databases were examined to collect data, including Web of Science, PubMed Central, Medline, Embase and Cochrane. Our study examined several randomized controlled trials, including randomized clinical trials and randomized controlled trials that involved TTM interventions in adult OHCA patients. An analysis was conducted based on the search criteria for screening, collecting, and extracting data. Based primarily on qualitative analysis, a synthesis was conducted. There were 21 studies with a total of 11435 participants, with a median sample of 355, and none of them demonstrated sufficient qualitative and quantitative evidence indicating that TTM interventional variants were safe, feasible, efficient, and effective on neurological and mortality outcomes in OHCA patients.

10. Formulation and Development of Polyherbal Ointment containing Clerodendrum serratum, Solanum xanthocarpum, and Nyctanthes arbortristis Extracts and Assessment of Anti-inflammatory Activity in Carrageenan-Induced Paw Edema Model
Sandip G. Laware, Nitin L. Shirole
In this study, our objective was to explore the phytochemical constituents of Clerodendrum serratum (CS), Solanum xanthocarpum (SX), and Nyctanthes arbortristis (NA) and evaluate their anti-inflammatory activity. Subsequently, we aimed to develop a polyherbal ointment formulation incorporating these extracts. The phytochemical screening of the CS extract showed carbohydrates, steroids, terpenoids, flavonoids, saponins, and tannins. Similarly, the SX extract exhibited the presence of all these constituents, along with the additional presence of alkaloids. The NA extract demonstrated the presence of alkaloids, tannins, glycosides, and flavonoids. CS roots exhibited notable inhibition of inflammation at the given doses and periods of 1 to 5 hours, surpassing the effectiveness of the standard anti-inflammatory drug, indomethacin. The polyherbal ointments were found to be greenish, non-transparent, and with acceptable pH. F3 formulation demonstrated excellent viscosity of 1200 cp, making it easy to apply on the skin. Furthermore, formulation F3 demonstrated exceptional spreadability, covering a diameter of 1.8 cm, surpassing the other formulations. Importantly, all polyherbal formulations were non-irritant when applied to the skin, as evidenced by the absence of edema or erythema upon application to rat skin. F3 formulation indicated no physicochemical variations in comparison to initial results in stability studies. Even after the 6-month stability study, the ointment formulation maintained a smooth and greenish consistency, signifying its durability and stability. These findings suggest that the developed polyherbal ointment formulation can be stored at room temperature without any additional requirements. Overall, this polyherbal ointment formulation represents a promising alternative approach to existing topical formulations for the effective treatment of inflammatory conditions.

11. A Stability Indicating RP-HPLC Method for the Estimation of Nebivolol Hydrochloride in Human Plasma
Kaveri T. Vaditake, Atul A. Shirkhedkar
Nebivolol hydrochloride is used as a ꞵ1 receptor and calcium channel blocker to treat hypertension. This research aims to provide novel stability indicating reverse phase high-performance liquid chromatography (RP-HPLC) approach for estimating nebivolol hydrochloride in human plasma. The protein precipitation technique used 5% formic acid and methanol to extract the plasma. The separation was accomplished by using Inertsil ODS-3V (150 mm X 4.6 mm, 5μm) column, using acetonitrile: 0.1% trifluoroacetic acid in water (40:60% v/v) as a mobile phase, at flow rate of 1.0 mL/min and detection was done on a photodiode array detector at 282 nm. The retention time was found to be 5.55 minutes. Linearity was observed between 4.50 to 180 μg/mL with R² values of 0.999. No interference was detected in the drug retention times in selectivity and sensitivity. Accuracy as well as precision were observed within limit. All the analytical validation parameters were determined as per the USFDA guidelines. The stability study was conducted on NBH containing human plasma using two levels, LQC and HQC, exhibiting that the drug was stable under different conditions. The conveyed RP-HPLC method for estimation of NBH was simple, precise, and accurate; therefore, it can be used in bioavailability and bioequivalence studies, pharmacokinetics and toxicology studies of NBH in human plasma.

12. Comparative Materiovigilance Program for US, Europe, Japan, India and Proposed Reporting Mechanism for Indian Scenario
Manvendra S. Teli, Vikas Jhawat
Medical devices are thought to be a blessing for the healthcare system because they are tools that can save lives. Apart from therapeutic potential, these devices have lot of negative side effects. It took a strong cohort attentive system to control such negative impacts. As a result, materiovigilance was introduced. Materiovigilance is the investigation and monitoring of incidents brought on by the use of medical devices. It controls adverse events (AE) and brings about international harmony. These goals are kept in mind when the principles, viewpoints, and materiovigilance techniques in the USA, Europe, China, Japan, Australia, Canada, and India are contrasted. It is crucial to make this comparison to comprehend the shortcomings of the current regulatory frameworks in the nations described above. Additionally, it will give the regulatory authorities a complete picture so they can alter any existing legislation as necessary. In the present study, an ideal proposed model of medical devices for its approval has been explained easily.

13. Formulation Development and Evaluation of Freeze-dried Aviptadil Injection using Mannitol as Cryoprotectant
Amit Bukkawar, Amit K. Jain, Vivekanand K. Chatap
Introduction: The naturally occurring human polypeptide known as vasoactive intestinal polypeptide (VIP) has a variety of physiological effects that have been well-documented, including anti-inflammatory, immune-modulatory, anti-hypertensive, enhancement of cardiac contractility, vasodilation, and fostering immune-neuroendocrine connection. Aviptadil (AVP) is the name of the vasoactive intestinal polypeptide’s synthetic version. Aims and Objectives: The main goal of this work was to create a novel, stable, lyophilized version of aviptadil injection. The stability of aviptadil is of utmost importance due to its classification as a polypeptide, recommended storage condition of -20°C, and susceptibility to degradation in aqueous solutions. To achieve this, the aviptadil injection was processed using freeze-drying technology with the addition of mannitol, serving as a bulking and cryoprotectant agent, within an aqueous solvent system. The choice of cryoprotectant and solvent system was based on factors such as the drug substance’s solubility, stability, and feasibility in the manufacturing process. During the development of the formulation, the bulk solution underwent evaluation to assess the effects of process time, temperature, and compatibility with the materials it came into contact with. Results and Discussion: The incorporation of mannitol, a sugar alcohol, led to the stability of the bulk solution for up to 24 hours before lyophilization when stored at temperatures between 2 and 8°C. Moreover, enhanced stability was observed post freeze-drying. The lyophilization process was meticulously optimized, taking into account critical quality attributes such as description, active drug content, pH of the reconstituted solution, reconstitution time, moisture content, and color absorption percentage. The bulk solution demonstrated compatibility with various materials employed in manufacturing the drug product, such as stainless-steel vessels, polyethersulfone (PES) and polyvinylidene difluoride (PVDF) membrane filters. Notably, when the drug product bulk solution was kept refrigerated for up to 24 hours, there were no appreciable changes in the critical quality features found. The optimized freeze-dried product successfully meets the quality target product profile (QTPP)’s preset acceptance criteria. Conclusions: The stabilization of AVP injection was successfully achieved through the implementation of the lyophilization process with mannitol as the cryoprotectant. The envisaged injectable formulation proves to be safe and showcases its economic viability, convenience, and overall safety in the preparation methods. These findings strongly support the viability of the freeze-dried formulation as a technically sound solution for ensuring the stability of aviptadil as a drug substance within the freeze-dried injectable dosage form. This formulation warrants more research due to its potential to treat patients with conditions such acute respiratory distress syndrome, acute lung injury, pulmonary fibrosis, and sarcoidosis.

14. Engineering Low-Cost Banana Peel Derived Biochar for the Highly Adsorption Capacity of Metformin Hydrochloride Drug from Aqueous Solution on Chemical Activation
Ali H. Aboreghif, Sarmad D. Noori, Saja H. Kareem, Mohammed S. Hamza, Talib K. Hussein
Adsorption is one of the easiest and best ways to purify water. In recent years, the adsorption process has been adopted to purify drinking water. Using adsorption technology to remove the most dangerous types of pharmaceuticals in drinking water, such as (metformin hydrochloride MF-HCl drug), and a primary goal of this empirical study utilizing banana peels as derived biochar activated carbon (ACBP) to remove MF-HCl drug. The FTIR, FE-SEM, XRD and TEM technique was utilized to estimate the surface characteristics before and after the adsorption process. The adsorption capacity Qe mg/g and percentage removed E% increase with increasing equilibrium time and, solution temperature and pH. The adsorption capacity Qe mg/g Qe mg/g decreases with increasing of adsorbent dosage. Thermodynamics including (ΔH), (ΔS) and (ΔG) are found to be endothermic and spontaneous. Results show that the MF-HCl drug adsorbed amount on ACBP was 147.59 mg/g. The adsorbent was treated via several acids like as (H3PO4, HNO3, HCl and H2SO4). The obvious from the results the best removal percentage E% when the adsorbent was treated via HCl. This is may be due to the increase in acid acidity caused by reactivating the active sites for the adsorbent surface. From the results obtained, ACBP are eco-friendly, extensive, and effective as an adsorbent, giving a promising prospect for removing wastewater.

15. A Correlative Dissolution Study of Oral Drug Delivery Systems through Reverse Phase-HPLC Analysis
S. Poongothai, R. Srinivasan, M. Rama
Oral drug administration is essential for treating diverse diseases due to its acceptable route, non-invasiveness, minimal off-target side effects, versatility, and painless patient delivery. However, multiple drug accessibility is increasing currently but there is often a deficiency of indication in developing procedures with assessment of two diverse medicinal formulations. Oral administration of a novel antiepileptic drug, levetiracetam in grouping with either L-dopa unaccompanied or L-dopa/Ropinirole treatments was associated with dyskinesia. Altered shooting patterns of neurons relating to a compulsive harmonization process may back to the origin of dyskinesia. The current study aims to develop a dissolution technique and validate the antiparkinsonian drug-ropinirole and antiepileptic drug-levetiracetam tablets by RP-HPLC, which plays a major part in pharmaceutical formulations. The optimal dissolution conditions were experienced for the products respective to the pharmaceutical formulation and applied to assess the dissolution profiles. Ideal settings for the dissolution method were500 mL of pH of 4.0 citrate buffer, 50 rpm and 250 nm for ropinirole tablets and 900 mL of distilled water, the rotation speed of paddle 50 rpm and 217 nm for levetiracetam tablets, then 3.84 and 3.87 minutes were set as the retention time of ropinirole and levetiracetam tablets, respectively. Technique optimization and validation process helps to reduce the bioequivalence of both dosage forms. The current study ensues detailed information on the drug release, even if there is a change in pH medium, filter, rpm, instrumentation, etc. Focusing on current pharmaceutical sciences, the proposed correlative dissolution study coupled with RP-HPLC analysis could offer a holistic insight into the performance of future oral drug delivery systems.

16. Evaluation of Antidiabetic Activity of Various Extract of Peristrophe bicalyculata (R.) Nees.
Sumeet Dwivedi, Udita Singh, Prakash C. Patel, Rahul S. Bijwar, Supriya Shidhaye, Arun Patidar
In the conventional medical system, India’s population depends on ancient medicine systems like Ayurveda, Homeopathy, Siddha and Unani for the treatment of disease. With such a large population relying on herbal remedies, scientific support for the efficacy of herbal products that have been used for a long time is essential. Diabetes is predicted to become more common worldwide. According to WHO, developing nations will bear the majority of the burden. Peristrophe bicalyculata (R) Nees. belongs to the Acanthaceae family. It is native to Afghanistan, Africa and India. The plant’s flowers are used medicinally to treat various diseases and disorders. The present paper shows the antidiabetic activity of hydro-alcoholic extracts of P. bicalyculata (R) Nees flowers was investigated using an animal model.

17. UV Spectrophotometric Analysis of Apigenin in Topical Fungal Formulation containing Extract of Leonotis nepetaefolia (L) R. Br.
Sumeet Dwivedi, Supriya Shidhaye, Abhishek Dwivedi, Sumit Prachad, Ishika Mishra, Amit Gangwal, Abhishek Kumar
Fungal infections continue to endanger human health, and the problem is only becoming worse. Combination therapy may be an optional strategy for the treatment of invasive fungal illnesses, and the potential antifungal mechanisms provide new insights into the development of innovative antifungal medications. Numerous investigations have shown that combining plant extract showed significant antifungal activity. In the present work, a topical fungal formulation containing hydroalcoholic extract of Leonotis nepetaefolia (L) R.Br. (TFF) in form of a cream was estimated for apigenin. A technique has been created and validated using UV spectrophotometric analysis in order to evaluate the aforementioned drugs simultaneously in the formulation.

18. Supercritical CO2 Extraction, Quantification and Pharmacological Screening of Steroidal Saponins from Fruits of Momordica charantia L
Shailaja Jadhav, Adhikarao Yadav
Momordica charantia L. (MC), a Cucurbitaceae family member, is the most recognized plant for its hypoglycemic activity. Charantin, a steroidal saponin, is the most studied potent phytochemical in MC for diabetes. This research paper aims at the extraction, quantification and pharmacological screening of charantin, from fruits of MC. Extraction was performed by using traditional soxhlet extraction and modified supercritical fluid extraction (SFE) techniques, and compared the results of both techniques in terms of percent extract yield, quantity of charantin and in-vitro antidiabetic activity of both extracts. (Soxhlet extract and SC-CO2 extract). Further, quantitative estimation of charantin in both extracts was done by HPLC-UV method and it was validated as per the ICH guidelines. When compared to soxhlet extract, the SC-CO2 extract displayed high antihyperglycemic activity by blocking α-amylase and α-glucosidase enzymes. Study also indicates that SC-CO2 extract had higher antioxidant activity (0.25 mg/mL) than soxhlet extract (0.33 mg/mL), signifying the SFE technique’s efficiency over the traditional soxhlet extraction method. In-vitro antidiabetic study indicated that the biomolecule charantin extracted from fruits of MC possess potent antidiabetic and high antioxidant activities and, therefore, hold potential for manufacturing innovative natural remedies to treat diabetes and its complications with no side effects.

19. Stability Indicating Assay Method Development and Validation of Sitagliptin and Metformin Combination Tablets by Reverse Phase – HPLC
Gogada V. P. Rao, Meka Lingam, Bavisetti Lakshmi, Anantha L.Vadivelu, Duvvuri Suryakala
Two pharmaceutical compounds were isolated, separated, and confirmed using chromatographic techniques. The method involved utilizing an inertsil phenyl analytical the analytical column has dimensions of 250 mm x 4.0 mm and contains particles with a size of 5 μm. A solution is filled as a buffer, combined with a mobile phase containing a grid. with a pH of 4.0 made from potassium dihydrogen phosphate, orthophosphoric acid and of acetonitrile in a 70:30 ratio 0.8 mL per minute. The column temperature is maintained at 30℃ as part of the setup. The detection of the two drugs is continuously monitored using this setup. A wavelength of 210 nm using a UV detector with injection volume 20 μL. Forced degradation studies are carried out using PDA detector. Peak homogeneity explained as peak purity using lab solution software.

20. Dasatinib and Hesperidin Loaded Nano Formulation and Preclinical Evaluation for Anticancer Activity
Moinuddin, Sachin Neekhra, SK Swarnkar, Puneet Gupta, Deepa Gupta, Alok Khunteta, Ujjwal Kaushik, Saeem Ahmad
In this study, we aimed to develop Dasatinib/hesperidin-loaded-SLNs for chronic myeloid leukemia (CML). Utilizing a high-shear homogenizer for the synthesis, “central composite design (CCD)” was used to enhance the dasatinib/hesperidin loaded-SLNs. The optimized SLNs had PDI, particle size, and average entrapment efficiency of 0.12%, 162.3 nm, and 93%, respectively. Therefore, by enhancing the total amount of Compritol as well as sonication time the polydispersity was increased. Poloxamer 188 content had a significant influence in decreasing the polydispersity index and the entrapment efficiency (EE) of the SLN was found to be 93%. Through TEM, SEM, FTIR, DSC, and HPLC analysis, SLNs were characterized, and their anticancer efficiency was assessed in both in-vitro and in-vitro cell viability tests (MTT). SLNs containing dasatinib and hesperidin have rounded and spherical shape having a diameter of 200 nm. DSC and FTIR tests showed compatibility between the drugs and excipients. The drug release from optimized SLN formulation was under observation for 48 hours. It was found that the medication released its drug components over a protracted period of time, with 30% of the drug being released in the first four hours and the remainder 76% in the next 48 hours. According to the IC50 values determined by an independent study, dasatinib, hesperidin, and SLN were 33.97, 5158, and 4.03 μg/mL, respectively. A comparison of SLN and free drugs revealed that SLN was more effective at cytotoxicity. In this study, dasatinib and hesperidin-loaded SLNs for chronic myeloid leukemia (CML) against HL60 human leukemia cell lines were prepared and evaluated using a novel formulation approach free of toxic excipients.

21. Evaluation of Oral Bioavailability and In-vivo Anti-leukemic Potential of Dasatinib Loaded Solid Lipid Nanoparticles
Moinuddin, Sachin Neekhra, Saeem Ahmad, SK Swarnkar, Deepa Gupta, Alok Khunteta, Pankaj Jain, Sonika Jain
Dasatinib is one of the second-generation tyrosine kinase inhibitors (TKI) that is taken orally and has antiproliferative activity against chronic myeloid leukemia (CML). Dasatinib/hesperidin loaded-SLNs were synthesized in-house using a high-shear homogenizer and optimized by central composite design (CCD). Oral bioavailability and in-vivo anti-leukemic potential of developed dasatinib/hesperidin-loaded-solid lipid nanoparticles (SLNs) were determined using intravenous injection of leukemia cells in mice model. Dasatinib was administered as pure drug (suspension) and SLN formulation in leukemic mice modal. The pharmacokinetic profile was studied and compared with drug suspension using HPLC. Results denoted mean maximum plasma concentrations Cmax as 184.52 and 390.43 ng/mL, mean Tmax as 2 and 4 hours, mean half-life as 4.63 and 8.06 hours., for pure drug (suspension) and SLN formulation, respectively. The mean area under the curve (AUClast) was 1080.94 and 3669.49 hr*ng/mL for the same. SLN also showed statistically significant survival. A comparison of SLN and free drugs revealed that SLN was more effective at cytotoxicity. Therefore, the developed dual-targeted SLN formulation of dasatinib demonstrated higher sensitivity of cells to the drug entrapped in SLN than the drug suspension.

22. Formulation and Evaluation of Film-Coated Alalevonadifloxacin Mesylate Tablet using Opadry®
Phutane PK, Salunke SA, Kokate SV, Gunde MC, Suruse PB
Purpose: In this work, film-coated tablets of the antibiotic alalevonadifloxacin mesylate (AFM) were made using Opadry® yellow as the film coating material, and their different parameters, including in-vitro drug release, were assessed. Method: Direct compression was used in the production of film-coated tablets of AFM. The film-coating substance was an aqueous coating dispersion that was opadry yellow. In 900 mL of 0.1N HCL solution, the film-coated tablets’ rate of dissolution was assessed. In-vitro drug release was also evaluated. The generated film-coated tablets’ stability was assessed in accordance with ICH recommendations. Result: The coated tablets were subjected to gastrointestinal pH testing to ascertain the effectiveness of the film coating, and high-performance liquid chromatography was used to assess drug release. The coated tablets were in perfect condition. The AFM release satisfied the study’s requirement of being at least after 30 minutes, 80% was dissolved in a 0.5% HCl solution. Conclusion: According to these results, opadry yellow aqueous film coating is a simple, repeatable, and affordable method for creating stable AFM film-coated tablets without changing the properties of the medication release.

23. Antiepileptic Drugs Adverse Drug Reactions and Role of Clinical Pharmacist
Dharani Gopu, Akila Devi D
Aim: To identify the ADR of suspected adverse drugs to monitor, manage, and assess to improve patient health. Materials and Methods: The study type is a prospective observational study done in a tertiary care hospital at Telangana. Patients prescribed with at least one antiepileptic drug and patients with chronic diseases (SLE, renal and hepatic failure, etc.) were included in the study. Result: Sodium valproate shows relatively less adverse drug reactions (ADRs) (2.5%) when compared with other antiepileptics. Phenytoin shows the highest number of ADRs (50%), among which CNS-related ADRs, where more than 75% of were predictable clinical pharmacists can play a crucial role in the early identification and prevention of these ADRs due to Antiepileptic drugs.

24. Antimicrobial Activity and Cytotoxicity of “Bang Chang” Thai Cultivar Chili Pepper (Capsicum annuum Var. acuminatum)
Kanittada Thongkao, Pimporn Thongmuang, Yuttana Sudjaroen
Capsaicin is found naturally in the Solanaceae family of plants and linked to numerous health advantage. Capsaicin is also responsible for the antimicrobial properties of chili pepper. Thai Capsicum cultivar “Bang Chang chili pepper” (Capsicum annuum var. acuminatum), initially cultivated in Bang Chang subdistrict, Samut Songkhram, Thailand. This study aims to determine bioactive substances such as capsaicin and phenolic content, as well as antimicrobial activity against pathogenic bacteria, Staphylococcus aureus, S. epidermidis, Escherichia coli and Cutibacterium acnes) and yeast, Candida albicans, and cytotoxicity with human skin fibroblast cells. The TPC and capsaicin in the ethanol extract were 2.50 ± 0.13 mg GAE/g and 0.0104 ± 0.0 mg/100 mL, while in the oil extract were 0.0020 ± 0.0 mg/100 mL and 1.05 ± 0.05 mg GAE/g. Antimicrobial of this chili pepper was found in only oil extract that was inhibited against to C. albicans (inhibition zone = 10.68 ± 0.49 mm)There was preferrable when compared to fluconazole ((inhibition zone = 24.65 ± 0.25 mm). Both extracts (0.0001-1.0 mg/mL) had no effect on human fibroblast cells, implying that they are non-toxic. The finding may imply that non-pungent capsicum strains cannot inhibit bacterial growth due to low amount of phenolics and capsaicin contained. Capsicum variety and temperature of extraction were also affected on their property. As a result, oil extract was favored for C. albicans suppression. This pepper extract can be used as an antifungal agent, and a pharmaceutical formulation must be developed.

25. Novel HYDALJSS08 Polyherbal Formulation Development and Ultra-Performance Liquid Chromatographic Separation, Estimation of Gallic Acid in Terminalia chebula Dried Fruits, and a Marketed Siddha-based Polyherbal Formulation “Kabusura Kudineer”
Ramkishan Jatoth, Dhanabal S.P, Duraiswamy Basavan, Venkatachalam Senthil, Thangavel Ganesh, Jubie Selvaraj, Jeyprakash. M
The Siddha-based polyherbal formulation known as “Kabusura Kudineer (Marketed)” contains fifteen plants materials in dried raw form and The Ayush Ministry, Govt. of India highly endorsed for use of “Kabusura kudineer” during the pandemic of COVID-19, due to its immuno-booster properties. The current study aims to develop and document an analytical strategy for the estimation of gallic acid (GA) and methyl, ethyl acetate fraction of Terminalia chebula dried fruits and in polyherbal formulations (Marketed, & Developed). One of the active substances of Kabusura Kudineer and developed “HYDALJSS08” Polyherbal formulation is Myrobalan (T. chebula dried fruit-Combretaceae). Myrobalan restrains active principal substances are GA. GA is proven for its Anti-viral and immunomodulatory activity. During the pandemic of, COVID19 ministry of Ayush, Govt of India highly recommended the immuno-booster Siddha-based polyherbal formulation “Kabusura Kudineer” for immune-boosting and treatment of COVID-19. TLC, and FTIR carried out the preliminary identification of GA and the sample. The HPLC method was developed on an Inertsil C18 (150*4.6 mm and 5 μm) column. The mobile phase was enhanced for water: Acetonitrile (50:50). The flow rate was 1-mL/min and was GA tracked at 272 nm in a UV detector. The total run time of the chromatogram is 8 minutes and the retention time of GA is observed. The Rf value of GA and sample was found to be 0.27. Validation was carried out according to ICH guidelines. The retention time of GA was 2.2 min, and the Valid parameter of GA is system precision, SD (14247.75), %RSD (0.9), Regression equation y = 25511 x−947505, Correlation coefficient (R2) 0.9999. The adequate Linearity concentration was found to be 50 to 150 μg/mL, LoDs (1.70 μg/mL), LoQs (5.16 μg/mL), Method precision %RSD (0.8), SD (11626.7), Recovery 99.8, and 101.1%. GA content was found in a formulation (“Kabusura Kudineer”- 1.39 μg/mL, developed “HYDALJSS08” Polyherbal formulation-379.4 μg/mL), and ethyl, methyl acetate fraction of T. chebula dried fruits was 105.59 and 29.17 μg/mL. The developed (HPLC) UPLC methods have enabled novel, simple, accurate, rapid, easy, reproducible, rugged, and linear analysis in these two fractions, and Siddha-based formulation “Kabusura kudineer” (Marketed), a developed “HYDALJSS08” Polyherbal formulation.

26. Simultaneous Estimation for Diosgenin, Charantin and Hydroxychalcone from Herbal Antidiabetic Formulation using Validated HPTLC Method
Archana Naik, Chhaya Gadgoli, Nikita Patil, Ruchira Salunkhe
Most antidiabetic polyherbal preparations contain Trigonella foenum-graecum, Momordica charantia and Cinnamomum zeylanicum as active components. Although all ingredients are popular as antidiabetic agents, but the analytical method is not available for simultaneous estimation of marker compounds from herbal formulations due to several challenges. Hence, the HPTLC method was developed for simultaneous estimation of three active phytoconstituents viz. diosgenin, charantin and hydroxychalcone in polyherbal formulation. The stationary phase of the optimized HPTLC method is silica gel 60 GF254 and the mobile phase is chloroform: glacial acetic acid: methanol: water (4:3:2:1v/v). The Rf value of phytoconstituents charantin, diosgenin, and hydroxychalcone was found to be 0.72, 0.61 and 0.30 at detection wavelength 342 nm. According to ICH criteria, the analytical method validation was performed. All three markers showed linear and proportional responses in the 400 to 1400 ng/band range, which confirmed the markers’ linearity. Precision measurements were made at the intraday and interday levels, and the results were satisfactory and in line with the specifications. Accuracy was determined by the recovery method and %recovery was found to be in the range of 85.20 to 97.19. The validated HPTLC method was utilized to analyze the marketed Quanto Diab Forte capsule formulation containing charantin, diosgenin, and hydroxychalcone. The proposed validated analytical method was found to be simple, precise and accurate.

27. Chemometric Exploration of Photostability of Ornidazole in Aqueous Solution with Soft and Hard Modelling Multivariate Curve Resolution Method
Abhijeet Sutar, Tejas Dhole, Shruti Ringe, Shounak Kulkarni
The photodegradation study of ornidazole in an aqueous solution was performed by using the multivariate curve resolution-alternative least square technique. The sample solution was exposed to direct sunlight for 42 hours, and the spectroscopic data was obtained at predetermined intervals of wavelengths. MCR-ALS, which is a chemometric technique, was applied to the data set. Initially, soft modeling was used, followed by hard modeling. The results show that ornidazole undergoes photodegradation via a two-step process in an aqueous medium, with three species involved in the degradation process. The initial concentration of pure ornidazole decreases while the concentration of intermediate start increasing and the concentration of intermediate falls with the formation of a new product. Thus, we have got three pure spectra in the MCR-ALS process. The reaction kinetics was performed with the hard modeling technique using kinetic constrain and the rate constant of the reaction was found to be k1 = 0.0955 and k2 = 1.287, respectively.

28. The Implementation and Evaluation of Pharmaceutical Care Plan in Stroke Patients at Tertiary Care Hospital
Dharani Gopu, Akila Devi D
Objective: To assess the pattern and prevalence of adverse drug reactions (ADRs) reported by the neurology department and review the benefits of the pharmaceutical care plan. Materials and Methods: A total of 148 stroke cases with previous medication history correlated with current complaints leading to hospitalization were included in the prospective study for one year in the neurology department. Results: This study identified non-adherence (50%) and ADRs (38%). Ignorance of the disease, its complications, and the possible adverse effects of self-medication have been identified as risk factors. The medication-related problems were mainly observed with antimicrobials, central nervous system (CNS), central venous system (CVS), and inflammatory and immune modulators. Conclusion: The risk factors involved are illiteracy regarding prescribed therapy benefits. In the patient’s medication therapy, warfarin has more adverse events, and an observation of the patient’s plasma concentration levels increased.

29. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Gallic Acid, Scopoletin, Umbelliferone, and Imperatorin in Bael avaleha
Ganesh B. Nigade, Meenakshi N. Deodhar, Rajashree S. Chavan
Bael avaleha is a semisolid ayurvedic formulation containing the fruit of bael, which acts as an anthelmintic to treat diarrhea, dysentery, and IBS. It strengthens the gastrointestinal tract, heals ulcers, and alleviates abdominal pain. The avleha contains excess sugar, which can result in faster absorption of active ingredients in the biological system. Researchers have begun scrutinizing ayurvedic formulations for quality and consistency, with quality testing being conducted to ensure that the quality of ayurvedic formulations adheres to ayurvedic standards. Phytochemical fingerprinting by spectroscopic and chromatographic techniques is becoming more popular in assessing the efficacy of ayurvedic products. Previous studies evaluated phenolic compounds, flavonoids, monoterpenes, and sesquiterpenes in Bael fruit using Gas Chromatography Mass Spectrometry(GC-MS), HPTLC, and HPLC methods.This study evaluated marketed bael avaleha formulations (BA I and II) for organoleptic characteristics, physical parameters, and phytoconstituents. A UV-vis spectrophotometric study was conducted for quantitative analysis of phytochemicals. The extract of bael avaleha formulations BA I and BA II were found to have a total phenolic content of 42.34 ± 0.090 mg GAE/g and 38.52 ± 0.065 mg GAE/g, a flavonoid content of 14.34 ± 0.070 mg QE/g and 12.42 ± 0.086 mg QE/g, sugar content of 69.44 ± 0.020 mg Glu/g and 67.18 ± 0.065 mg Glu/g, and a reducing sugar content of 31.34 ± 0.025 mg Glu/g and 29.08 ± 0.047 mg Glu/g, respectively. The Fourier transform infrared (FTIR) spectra of extract of bael avaleha formulations were recorded in region 4000–400 cm−1 and confirmed the presence of hydroxy group, aromatic C-H stretch, C=C and C-O group. RP-HPLC method was developed and used for the estimation of gallic acid, scopoletin, umbelliferone, and imperatorin in the extract of Bael avaleha formulations.

30. Simultaneous Estimation of Curcumin and Vitamin E in Bulk and Cosmeceutical Formulation by UV Spectrophotometry
Shilpa R. Borate, Atishkumar S. Mundada
The goal of present study is to validate the developed assay method per International Council for Harmonisation (ICH) Q2R1 recommendations and create a sensitive, reproducible, and practical method for detecting curcumin and Vitamin E in pure and in cosmeceutical formulations. With the creation and validation of a straightforward, accurate, and repeatable UV spectrophotometric method, curcumin and vitamin E in bulk and cosmeceutical formulation may now be determined simultaneously. The need for a new technique to estimate curcumin and vitamin E in a cosmeceutical formulation has become more pressing due to the lack of a well-described UV analytical method for doing so. Q absorption at 231 and 285 nm were used in the calculation. Vitamin E (16–24 μg/mL) and curcumin (8–12 μg/mL) both behave according to Beer-Lambert’s law at the designated wavelengths. The recovery experiments verified the method’s adherence to ICH standards for accuracy, precision, and resilience. The method under consideration can be employed to accurately determine the quantities of vitamin E and curcumin present in a cosmeceutical formulation.

31. Application of Quality by Design in RP-HPLC for Robust Impurity Profiling and Stability Assessment of Doxylamine
Avinash Chavan, R. Gandhimathi
The primary purpose of this research was to create and validate a doxylamine detection method using reverse phase high performance liquid chromatography (RP-HPLC) for use in pharmaceutical formulations and bulk materials. Quality by design (QbD) served as the inspiration for this approach. The method was developed by running a C18 column at 1-mL/min through a mobile phase of 60 parts methanol to 40 parts 0.1% OPA water (pH 2.8). The detection was done with a UV detector set to 259 nm. All requirements for system applicability were satisfied by the suggested approach, including an acceptable asymmetry factor and an adequate number of theoretical plates. A correlation coefficient (R2) of 0.9990 was used to confirm linearity over a concentration of 10–50 g/mL. The approach showed good accuracy by a mean %recovery ranging from 99.59–101.45% and a %RSD between 0.11 and 0.81. Precision tests conducted both intraday and across days showed that the medication content stayed within allowable bounds. The approach was found to be robust, with only minor variations in flow rate, mobile phase composition, and detecting wavelength significantly affecting the accuracy and specificity. A 0.71 g/mL LoQ and a 0.23 g/mL LoD were determined to be analytical limits of detection and quantification, respectively. This study substantiates the development of a reliable, long-lasting, and cost-effective QbD-based RP-HPLC method suitable for the comprehensive analysis of doxylamine in tablet formulations and bulk dosages.

32. Formulation And Evaluation of Quercetin Loaded Nanosponges of Abiraterone Acetate
Suvarna Thorat, Manoj Tare
A novel idea in medicine delivery is the use of nanosponges. In the current research, an effort was made to create in-situ gel based on nanosponges that contained abiraterone acetate loaded with quercetin. The major purpose of nanosponges is to offer a prolonged release, lessen the negative effects of conventional dosage forms, and enhance the bioavailability of abiraterone acetate by using quercetin as a natural bioenhancer. Combining ethyl cellulose and eudragit in varying quantities, the quasi emulsion solvent diffusion technique was used to create nanosponges and quercetin as a natural bioenhancer. The formulation properties of the produced nanosponges were assessed. All batches of nanosponges had their manufacturing yield and trapping effectiveness assessed. Formulations F 03-P1 and F 07-P2 were found to be the optimum formulations based on results. Both F 03- P1 and F 07-P2 were used to create the gels G1 and G2. Viscosity, spreadability, drug content, and in-vitro tests showing 28.88% drug release after 24 hours all favored G2 as the optimal formulation. A gel base was created using the optimized formulation after it had been tested for scanning electron microscopy (SEM) analysis. Nanosponges containing gel had evaluated for different tests. According to the study, adding drugs to nanosponges can increase the rate of drug release, improve medication targeting at a particular spot, and hence lessen systemic toxicity.

33. To Synthesis and Characterization of Novel 1,3,4-Oxadiazinoindole Derivatives for the Purpose of Antidepressant Activity
Mahadev Agarwal, Neelam Singla, S. K. Singh
The present paper is based on the combination of MAOI hydrazide moiety and tricyclic antidepressant moiety. This combination investigates new compounds as 1,3,4-oxadiazinoindole derivatives to find potent and safer antidepressants. Synthesis of 1,3,4-oxadiazinoindole derivatives are started from various animoacids. The sequence of synthesis reactions such as benzoylation reaction, Halo-De-hydroxylation (Nucleophilic substitution reaction), Schotten-Baumann reaction, Nucleophilic addition and finally cyclization reaction (Cyclo-De-Hydroxylation) are involved. Synthesized compounds are characterized via melting point, TLC, FT infrared spectroscopy, 1H-NMR, and mass spectroscopy techniques. All compound’s structures are confirmed.

34. In-silico and In-vitro Studies on Targeting Tumor Apoptosis by Activating Caspase-3
Akula Sowjanya, G. Shiva Kumar
Background: Despite the availability of numerous treatment options, cancer remains the primary cause of death in the current decade. The present study integrates computational and experimental methods to identify and develop a novel promising compound with anticancer properties. The study aims to evaluate the potential anticancer properties of selected molecules based on docking score, compliance with Lipinski’s rule of five, and in-silico safety prediction. Structure drug design by molecular docking methods was used to explore ligand conformations at various target binding sites. The in-silico physicochemical, pharmacokinetic, and toxicology properties of designed molecules were predicted using online software. Further, in-vitro, anticancer properties were studied by MTT Assay and flow cytometry. Results: 2-Butyl-3- (3, 5-diiodo-4- hydroxybenzoyl) benzofuran is one of the selected ligands showed potent anticancer activity against HT- 29 (Human Colon Cancer) cells and A549 (Human lung cancer) at IC50 concentrations. Further apoptosis studies demonstrated the possible mode of action against HT-29 cells. The proposed mechanism of action may be caspase-3 activation. As a consequence of caspase-3 activation, enzymes such as DNase are activated, leading to DNA fragmentation and apoptosis, and DNA fragmentation was 6.5 times greater than in untreated cells. The IC50 concentration of 2-Butyl-3- (3, 5-diiodo-4- hydroxybenzoyl) benzofuran inhibited 50% of HT-29 cells during G0/G1 phase. Conclusion: This research contributes to the burgeoning field of integrated in-vitro and in-silico analysis of biological systems, which can be used to study complicated cancer cell population dynamics. Future studies should investigate the impact on Human lung cancer cells.

35. Removal of Cr (III) by using Chitosan-Grafting-Poly(Acryl Acid-Crotonic Acid) Characterization and Kinetic Study
Rasha A. Mohammed, Hazim A. Walli
Hydrogel nanocomposites were prepared using free radical polymerization chitosan and acrylic acid (AA) in combination with crotonic acid. KPS was employed as the initiating agent, while MBA functioned as the cross-linking agent. The nanocomposite of Ch-g-P(AA-co-CA) is a powerful pollutant absorber. Cr (III) was removed from the water using the combination. Field emission scanning electron microscopy (FESEM) and infrared spectroscopy (FTIR) were used to examine the nanocomposites’ structure and morphology. The kinetics of Cr (III) adsorption was studied using these rates. Pseudo-second order kinetics characterize the adsorption process. Hydrogel nanocomposite efficiently removes Cr by adsorption (III).

36. Pharmaceutical and Clinical Assessment of Multi-source Tegretol®  Sold In Egypt
Sarah K. Amer, Hany Eldeeb, AG Eshra
Background: Numerous studies have shown significant variability in quality and efficacy commonly exists upon switching across generic Narrow therapeutic index (NTI) medications compared to brands. However, little attention has been given to possible inequality within the same brand due to transportation and storage conditions, production site, manufacturing condition, and product specification requested by different countries. Market surveys has shown that Egypt is one of the countries suffering from this problem, which consequently augments the need for comparing and evaluating brand products marketed under the same brand name, manufactured in different countries under its own licensing trademark™ and sold in Egypt. This work studies the drug carbamazepine (CBZ) available in Egypt as Tegretol® tablets used as an oral first-line anti-epileptic drug (AED). Objectives: The present work investigate and evaluate the pharmaceutical quality and clinical efficacy of Tegretol®, obtained from Egypt and Saudi Arabia and being marketed and sold in Egypt from 2020 to 21. Methods: In-vitro quality testing included potency and uniformity of content tests performed according to USP 2019 monograph. Dissolution rates were also carried by adopting USP dissolution test for the drug. Studies of stability were adjusted at 25°C/65% RH, 45°C/75% RH and 10°C/15% RH. The clinical efficacy was studied by evaluating the pharmacokinetics parameters and blood sodium level during six months of therapy. Results: Variability between multisource Tegretol® brand products were ensured. Potency results and uniformity of content revealed statistically significant difference between Tegretol® sources. Also, variations in dissolution rates were recognized in both Tegretol® sources when dissolved in HCL/KCL, Acetate and Phosphate Buffer dissolution media. Dissimilarities were obtained for hardness and friability testing. Furthermore, a pharmacokinetically and pharmacodynamically inequivalence was ensured. Hence, hyponatremia was more prominent in patients receiving Saudi Arabian Tegretol® compared to patients taking Egyptian Tegretol®. Conclusion: Interchangeability between multi-source Tegretol brand products should be limited.

37. Liquid Chromatography Tandem Mass Spectrometric Method Development and Validation for the Quantification of Orlistat in Biological Matrices
K.V. Sundaram, D.V.R.N. Bhikshapathi
A specific, linear and precise liquid chromatographic-tandem mass spectrometric method was established and validated for the quantitation of orlistat in sample plasma. Zorbax C18 (4.6 mm i.d.× 50.0 mm; 5.0 μm) stationary phase was utilized to achieve chromatography elution, through a flowing rate of 0.90 mL/min. Isocratic elution was done using methanol, acetonitrile and 0.10% v/v HCOOH in a fraction of 80:10: 10 v/v/v as the mobile phasic system. For drug and internal standard separation, the precipitation extraction technique used acetonitrile as solvent. A triple quadrupole mass detector was employed for the quantification of ions. Electrospray ionization in a positive ionizing method, which was executed in multiple reaction monitorings (MRM) with parent/product ion transitions of m/z 496.4→337.31 for orlistat and 506.23→57.07 for amprenavir internal standard. The calibration graph was executed between the concentrations of 4.75–190.0 ng/mL and the resulting equation was y = 0.0058x + 0.0022 with r2 value of more than 0.99. Orlistat recovery values were found to be more than 93.65%, and its accuracy, measured in relative error, was in the range of -4.48 to 3.49%. Accuracy findings, sensitivity and recovery values of orlistat in the sample plasma for the established technique evidences its importance in pharmacokinetic and bioequivalence study.

38. In-vitro Antioxidant and Anti-Inflammation Activities of Ethanol Extract from “Bang Chang” Thai Cultivar Chili Pepper (Capsicum annuum Var. acuminatum)
Kanittada Thongkao, Yuttana Sudjaroen
Chili peppers (Capsicum spp.) are really important crops in several Asian countries. In Thailand, chili pepper cultivars are also a wide range of flavors, colors, shapes, and spiciness levels. The cultural importance in Thai cuisine. The “Bang Chang chili pepper” (Capsicum annuum var. acuminatum), a Thai cultivar of capsicum, had first cultivated in Bang Chang subdistrict, Samut Songkhram, Thailand. This study aimed to determine capsaicin, phenolic compounds and flavonoids and screen ethanol extract’s biological activities. The extract’s average capsaicin and total phenolic content (TPC) was 10.4 ± 0.3 (g/100 mL and 2.50 ± 0.13 mg GAE/g, while it could not determine flavonoids. The low amount of capsaicin in extract was defined this cultivars as non-pungent capsicum (0-700 Scoville Heat Units, SHU). This extract was strongly scavenged NO and DPPH radicals (IC50 = 0.09 ± 0.02 and 14.88 ± 1.59 mg/mL). There was also exerted in-vitro anti-inflammation activity by suppression of albumin breakdown (IC50 = 0.51 ± 0.05 mg/mL), which, can comparable to control, diclofenac diethyl ammonium (IC50 = 0.45 ± 0.01 mg/mL). Therefore, lipid peroxidation was weakly inhibited (IC50 >1,000 mg/mL) and unable to trap metals compared to vitamin E and EDTA. According to our finding, this extract was exerted biological properties like antioxidant and anti-inflammation, as well as being non-pungent, it can be used externally for medicinal purposes like as a muscle relaxant and massage oil to reduce subcutaneous fat. This extract can be used as a condiment in Asian recipes and other healthful dishes.

39. Hypolipidemic Activity of a Polyherbal Formulation in Triton WR-1339 and High Fat Diet-induced Hyperlipidemic Rats
Vishal Lad, Sufiyan Ahmad
In hyperlipidemic wistar albino rat models produced by triton and diet, the efficacy of polyherbal formulations containing four different plants was assessed. Rats exposed to Triton WR 1339 had their blood cholesterol and triglyceride levels raised. However, this was reversed when the rats were given syrup or a comparable formulation. Both formulations better lipid outlines in rats with high-fat diet-induced hyperlipidemia. Effects were marginally better with the usual medication Atrovastatin. Liver sinusoidal capillary dilations, cytoplasmic fatty infiltration, and granular degeneration were considerably reduced in polyherbal formulation-treated group II animals related with other groups. As per results, polyherbal formulations in dyslipidaemic circumstances reduce lipid levels by blocking the production of cholesterol and reducing lipid utilization.

40. A QbD Based RP-HPLC Method for Stability Indicating Impurity Profiling of Pyridoxine: Method Development, Validation, and Application
Avinash Chavan, R. Gandhimathi
Pyridoxine impurity profiling in bulk and formulations was devised and validated using a reversed-phase high-performance liquid chromatography (RP-HPLC) strategy. The technique was fine-tuned using an Analytical quality by design (QbD) approach, ensuring its dependability and sturdiness. Linearity, accuracy, and precision were carefully examined as key performance indicators. With a relative standard deviation (RSD) < 2%, the approach showed exceptional precision, excellent recovery rates (100 and, 101.2%), and a strong correlation value (R2 = 0.9990). The technique has been used successfully for impurity profiling, and because it indicates stability, it can be used for long-term stability studies. The work contributes to the body of knowledge and has applications for pharmaceutical quality assurance.

41. Nutritional Composition, Capsaicin Content and Enzyme Inhibitory Activities from “Bang Chang” Thai Cultivar Chili Pepper (Capsicum annuum Var. acuminatum) after Drying Process
Kanyapat Petcharaporn, Kanittada Thongkao, Pimporn Thongmuang, Yuttana Sudjaroen
Chili pepper cultivars come in a broad variety of tastes, colors, sizes, and spiciness levels due to various growth conditions. The significance of different chili peppers and other spices in Thai cuisine may be seen in dishes. This study evaluated the nutritional composition and capsaicin content from “Bang Chang” Thai cultivar chili pepper after drying, and the inhibition of lipase, tyrosinase and elastase enzymes from its oil and ethanol extracts. The nutritional composition of sun-dried chili pepper was high dietary fiber and beta-carotene, which were significantly high amount portion of Thai recommended dietary intake (RDI). According to calculations and definitions, “Bang Chang chili pepper” is a non-pungent Capsicum (0-700 SHU) since it contains a low amount of capsaicin. Total phenolic content was more abundant in ethanol extract (2.50 ± 0.13 mg GAE/g) than oil extract (1.05 ± 0.05 mg GAE/g). Compared to the positive control orlistat (IC50 = 3.26 ± 0.28 mg/mL), an anti-lipase drug, ethanol extract was 2.0 times more lipase inhibitory. In addition, ethanol extract was mildly anti-tyrosinase, while oil extract was non-activity. The anti-lipase activity of ethanol extract was due to phenolic content rather than capsaicin contained and this enzyme inhibition may act on active site. We found that ethanol extract of “Bang Chang” cultivar chili pepper yielded higher TPC content and more effective anti-lipase than oil extract. The finding provided benefits on applying this chili pepper on anti-lipase use and weight management.

42. Comparative Analysis of Antibiotic Prescribing Patterns for Dental Infections: A Retrospective Study in a Dental Clinic
Hiroj Bagde, Ashwini Dhopte
This research aimed to analyze and contrast the antibiotic prescription trends that occur in dentistry offices. for the management of dental infections. To fill out the data, each dentist enrolled in the study was asked to record antibiotics prescribed for 6 -8 months and then the records were collected. Recorded dental prescriptions for antibiotics served as the study’s source population, and the list of patients who brought their prescription cards to the dental office within the allotted window of time (January 1 to December 31, 2015) served as its sampling frame. Using a statistical technique, After selecting patient record cards that included at least one antibiotic during the course of the investigation, the appropriate size of the sample was determined. The study employed a retrospective analysis of prescribing data from 10 private dental clinics, encompassing a sample of dental infection cases and corresponding antibiotic prescriptions. Data on the type and frequency of antibiotics and patient medical history and age were collected and analyzed. Descriptive statistics and statistical tests were used to examine the relationships between antibiotic prescribing patterns and patient factors. The results revealed significant associations between medical history, patient age, and antibiotic prescribing patterns. The findings highlight the need for personalized prescribing approaches based on patient factors, standardized clinical processes, and cost-effective antibiotic choices. Improving compliance with clinical guidelines can help optimize antibiotic use and enhance patient outcomes in dental practice.

43. Exploring the Therapeutic Potential of Sedum lineare Thunb: Phytochemical Analysis and Identification of Active Bioactive Compounds
Sunil Kumar, A.K.S. Rawat, Akash Ved, Peeyush Bhardwaj
Objectives: This research aimed to explore the therapeutic potential of Sedum lineare Thunb by conducting phytochemical analysis and identifying active bioactive compounds. Materials and Methods: S. lineare Thunb samples were collected from Pune district, Maharashtra, India in December 2022. Preparation of extracts using a hydroalcoholic solvent (ethanol: water, 70:30 v/v). Phytochemical screening using established methods to determine the presence of alkaloids, flavonoids, glycosides, diterpenes, carbohydrates, saponins, and tannins. Quantitative determination of total phenol and flavonoid contents in the hydroalcoholic extract. Identification of the marker compound (quercetin) in the S. lineare Thunb extract using HPLC. Results and Discussion: Alkaloids, glycosides, flavonoids, diterpenes, carbohydrates, saponins, and tannins were all found in the crude extracts by phytochemical analysis. The hydroalcoholic extract exhibited total phenol and flavonoid contents of 2.75 and 1.452 mg/100 mg, respectively. Quantitative estimation of quercetin in the hydroalcoholic extract was determined to be 0.0148%. Conclusion: The study demonstrated that S. lineare Thunb extracts contain various secondary metabolites, including phenolic compounds, flavonoids, and other bioactive compounds. The hydroalcoholic extract showed significant total phenol and flavonoid contents, indicating its potential therapeutic value. Further research is warranted to explore the specific health benefits and therapeutic applications of the identified bioactive compounds in S. lineare Thunb.

44. Confidence in Oral Cancer Awareness among Undergraduate Health Profession University Students at Al-Quds University
Nour Qawasmeh, Mohammad Assaf, Deniz Noyun
Background: Oral cancer is the sixth most commonly diagnosed cancer in the world. Still, awareness of this disease among undergraduate health profession university students is insufficient. Many students lack an understanding of risk factors and early signs of oral cancer. Therefore rises a need to increase awareness of oral cancer among health profession graduates so that they may be trained to recognize, diagnose, and properly manage this potentially deadly disease. Method: This study aimed to assess the current awareness and knowledge in oral cancer, focusing on prevention, early detection and adequate referral amongst undergraduate students studying a healthcare profession at Al-Quds University. This was a qualitative survey conducted among 64 senior students at various health profession undergraduate programs. The survey was distributed online and included questions about prevention, early detection, adequate referral, and overall confidence. Results: The results of the survey indicate that dental students had a higher confidence level in the subject of oral cancer than non-dental students, with the highest levels of confidence in prevention and lower levels of confidence in adequate referral. Additionally, the results suggest that a larger proportion of non-dental students showed lower confidence in the survey, and a higher proportion of dental students showed higher confidence. Conclusion: In conclusion, this survey revealed that dental students had a higher level of confidence in the areas of prevention, early detection, and overall confidence than non-dental students. Additionally, more emphasis on these aspects is recommended for all health profession students in necessary.

45. Assessment of Prescription Patterns and Appropriateness of Antibiotics for Prophylaxis in Dental Procedures: A Retrospective Study
Ashima Jakhar, Nitesh Dahiya, Amit Patil, Himmat Jaiswal, Sheetal Mali, Deepak Sharma
There is a lack of data on dentists’ prescribing behaviors when it comes to the correct use of antibiotics in dental treatments. Antibiotic prescriptions made by dentists were analyzed from a diagnostic perspective in a countrywide study. This study retrospectively examined national health data from January 2018 through August 2019, collected through the Prescription Information System. The analysis only included prescriptions for a single illness and at least one systemic antibiotic. Antibiotic prescribing practices and the role of dental specialization and diagnosis were studied. A total of 9,214,956 prescriptions out of 9,293,410 matched the criteria for inclusion. An average course of antibiotic treatment consists of 1.01 pills. Antibiotics were prescribed most frequently for dental caries (16.2% of cases), dental examinations (20.7% of cases), and periapical abscess without sinuses (28.1% of cases). Antibiotics were prescribed for 96.6% of patients for illogical or confusing reasons, whereas just 3.4% were given based on a single, unambiguous diagnosis, such as cellulitis or a mouth abscess. The most commonly prescribed treatment for any medical issue was amoxicillin combined with an enzyme inhibitor (58.6%). Compared to unidentified dental practitioners (58.2%; p = 0.0001), dental specialists in Groups A and B significantly overprescribed amoxicillin plus an enzyme inhibitor (67.0 and 67.8%, respectively; p = 0.0001) (data not shown). The results of the study suggest that dentists routinely and arbitrarily prescribe antibiotics with questionable rationale in the contexts studied. These results emphasize the need for dentists to begin prescribing antibiotics more deliberately and evidence-based. Educational programs, awareness campaigns, and antibiotic stewardship programmes are just some of the interventions that may be implemented to improve prescribing practices and ensure the correct use of antibiotics in dental operations. The results of this countrywide study highlight problems with dentists’ procedures for prescribing dental antibiotics. The paper states that dentists should base their prescription practices on sound reasoning and empirical data. Dentists can help with global efforts to lower antibiotic resistance and improve patient care if they prescribe them in a more reasonable and responsible manner.

46. Chemometric Assisted UV-Spectrophotometric Quantification of Cefaclor in Suspension Dosage Form
Kirtimaya Mishra, Budumuru Padmasri, Swetha Vegesna, Asra Jabeen, Abhilash Dash, Satyam Kumar, Diptimayee Jena
In this current study, the quality by design (QbD) concept is used for creating and validating a unique, resilient, accurate, and reliable spectrophotometric approach to quantify cefaclor (CEF) in injections. Fractional factorial design (FFD) was a design implemented to screen the initial parameters. Moreover, the variables went through the central composite design (CCD) to assess the dependency and optimize the design. Several measures were analyzed statistically to determine the appropriateness of the data obtained from the experiments. At 265 nm, by the use of ethanol, cefaclor displays an absorption maximum. Variables like screening, slit-width, and sampling interval were recognized as critical methods and again, evaluation was done by a CCD. A good linearity was produced for cefaclor in the range of 2 to 12 μg/mL, with R2>0.9993. The process was determined for being perfect, having a good average percent recovery (greater than 100%). According to ICH guidelines, validation of the developed method was performed. By implementing QbD principles, the spectrophotometric was created and designed to integrate the quality into the method. The process was manifested for being flexible and appropriate for identifying CEF in pharmaceuticals.

47. Development of a Simple Accurate Method, Validation and It’s Degradation Studies of Nirmatrelvir, Ritonavir in Bulk and Marketed Formulation by RP-HPLC
David Blessing Rani J, Asha Deepti C
An easy, accurate, and precise method used for simultaneous quantification of nirmatrelvir, ritonavir in bulk and marketed formulation by reverse phase high performance liquid chromatography (RP-HPLC) using a standard column Inertsil ODS (150 x 4.6 mm, 5 μm ) at a rate of flow 1-mL/min, acetonitrile and buffer containing hexane sulphonic acid, 50:50 v/v as a mobile phase was introduced through the HPLC column, detected at a wavelength 258 nm. Nirmatrelvir and ritonavir retention times were 2.481 and, 3.873 minutes, respectively. %Recovery rates for nirmatrelvir and ritonavir were 100 and 100.3%, respectively. LoD and LoQ values for nirmatrelvir and ritonavir were 1.5, 1 and 4.5, 3 g/mL, respectively. Nirmatrelvir regression equation is y = 32885.25x + 4223.04 while ritonavir is y = 39086.65x + 1680.21. Stability indicating studies done by acid, alkali, peroxide, Reduction, thermal, neutral and ultra violet light. The newly created reverse phase HPLC method, for bulk and marketed formulation, was rapid, stability indicating and accurate.

48. Correlation between Serum Troponin-I Levels and Acute Stroke in Coronary Artery Disease Patients
Shilpa Patil, Dilip Patil, Amit Porwal
Background: Studies reveal that the average age of stroke in less developed nations would be younger due to changing population structures brought on by increased mortality rates and other causes of death. The risk of death for AS patients is highest in the first few weeks and varies from 20 to 50% in the first month, depending on age, severity of stroke, other medical disorders, and treatment effectiveness for all outcomes. Furthermore, Tn subunits bind to muscle filaments, according to studies. Since it is a sensitive sign of myocardial necrosis, researchers have determined that it is widely used to diagnose acute coronary syndromes. Objective: To assess the link between serum TnI levels and AS in CAD cases. Methods: Based on the average patient volume and available resources at the KIMS, Karad from October 2017 to December 2019, our study comprised 57 patients. A structured and validated questionnaire was utilized to collect data. Microsoft Excel received the data. Tests were conducted using Epi-Info 7.2 and SPSS version 20. The student’s t-test is used to determine correlation, whereas the chi-square test was utilized to measure association. Result: A strong correlation was observed between mortality and elevated TnI levels in AS cases (p < 0.001). Conclusion: Patients with AIS showed significant TnI levels. Serum TnI levels were higher in patients with AIS, despite these levels being thought to be more selective for myocardial damage. TnI levels and AIS prognosis were substantially associated. The results of this study will improve our understanding of cardiac enzymes in AIS patients as well as how they impact prognosis.

49. Stability Indicating LC-MS/MS Method Development and Validation for the Quantification of Cabotegravir in Biological Samples
Palakollu D S Sankar, Naresh Panigrahi
The major goal of current research study was to create a sensitive tandem mass spectrometric method using electrospray ionisation and liquid chromatography for quantifying cabotegravir in biological matrices. A stationary Phenomenex C18 column with dimensions of 50 × 4.6 mm and 5.0 μm particle size of was used to achieve chromatographic elution. With the flowing rate of 0.80 mL/min, isocratic separation was done using methanol and 0.10% V/V HCOOH in a fraction of 85:15 V/V as the mobile phasic system. For drug and internal standard separation, liquid-liquid extraction was carried out using methanol and ethyl acetate (1:4) solvent solution. On repeated reaction monitoring, fragment and product ionic values were seen at m/z 406.12→142.04 for cabotegravir and 450.12→160.03 for bictegravir internal standard. Drug’s linearity graph had a r2 value of 0.9998 and was rectilinear at concentrations between 400 and 16000 ng/mL. The inter- and intra-batch accuracy %relative standard deviation values ranged from 2.54 to 5.21. The percent recovery results of the lower quality control (LQC), median quality control (MQC), and higher quality control (HQC) sample solutions were 102.85, 97.84, and 94.27%, respectively. This approach has excellent recoveries. Studies on stability were processed under various circumstances, and stability values ranged from 92.93 to 103.89%. When exposed to various stability conditions, cabotegravir is more steady for a longer time, and the approach was successfully applicable to routine examination of cabotegravir in biological samples.

50. New Amino-Anthracene-9, 10-Dione Derivatives: Synthesis and Pharmacological Evaluation as Powerful Neuroprotective and Antidepressant Agents
Chandrakant Suryawanshi, Rajendra Wagh
The monoamine oxidase (MAO) enzyme resides in the outer mitochondrial membranes of all body cells, including the ones found in the brain, liver, and intestinal mucosa. Dopamine, serotonin, norepinephrine, tyramine, and tryptamine are extrinsic and indigenous amines that MAO oxidatively deaminates. MAO-A has been correlated with depression and other mental health issues, while MAO-B has been associated with the conditions Alzheimer’s and Parkinson’s disease. In a targeted assessment of naturally occurring anthraquinones, two isoforms of recombinant human MAOs were utilized. The inhibitory effects of purpurin and alizarin on MAO-A were observed, with calculated IC50 values of 2.50 and 30.1 M, respectively. This research on anthraquinones, purpurin, and alizarin offers promising new information that might eventually be used as a lead molecule in the discovery of the unique synthetic anthraquinones, anthracene 9, 10-dione compounds 1 to 9. On 96-well black polystyrene microtiter plates, both MAOs inhibiting action of 9 distinct synthetic anthracene 9,10-dione compounds has been evaluated. Compared to clorgyline, compounds 1, 2, 5, 8, and 9 inhibit MAO-A significantly, while compounds 1, 3, 5, 8, and 9 considerably inhibit MAO-B. Significant findings indicate that these compounds may be beneficial When employed to treat depression owing to their intense selective MAO-B activity and antidepressant effects as a result of their selective MAO-inhibition.

51. Formulation and Evaluation of Herbal Remedy for Cough
Anjali Bedse, Ashwini Nalawade, Suchita Dhamane, Ramanlal Kachave, Vijay Wagh, Harshal Tare, Gauri Ghangale
The most frequent reason patients seek medical assistance is because of a persistent cough, despite the fact that coughing is both a crucial defensive reflex and a universal indication of health. According to an epidemiologic study, up to 40% of people report coughing. Upper respiratory tract infections (URTIs) and the common cold are the most frequent causes of cough, but other causes include post-infectious cough, undiagnosed chronic cough, and cough brought on by pulmonary diseases like asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, and lung cancer. The most common causes of cough in children are viral URTI, chronic bacterial bronchitis, and asthma. Whether acute or chronic, cough is linked to considerably reducing health-related quality of life. Patients with chronic cough commonly report sleep disturbance, nausea, chest pains, lethargy, social humiliation, urine incontinence, and low mood. Coughing may not be effective in certain circumstances (such as respiratory tract inflammation, neoplasia, eosinophilic bronchitis, airway irritation from various pollutants, airway hyperresponsiveness from infection, gastroesophageal reflux disease, and coughing without any known cause, also known as idiopathic cough). Opioidergic central cough suppressants, such as opioids, codeine, pholcodine, noscapine, and dextromethorphan, are useful when coughing is ineffective. Constipation, sedation, respiratory depression, dependence, drowsiness, addiction, and even mortality can result from prolonged use of these cough suppressants, which restricts their use in people. The proposed research project’s objective is to develop and assess herbal dosage forms that contain the widely used spice Piper longum L. (Piperaceae).

52. Derivatization of Proline for the Enantiomeric Separation and Estimation of D-Proline in L-Proline by NP-HPLC
Gampa Nagamalleswari, M.S. Umashankar
The core object of this exertion is to progress and validate a modest, competent and explicit method for the exodus of D and L isomers of proline in a racemic mixture and limit the content of D-Proline in commercial L-Proline. This has been technologically advanced in a chiral method using normal phase HPLC on CHIRALPAK-IA (250X4.6 mm) 5 μ column. This progress advanced with polar mobile phase ethanol encompassing modifier/additive TFA in 0.1% concentration. Due to the chromophore’s deficiency in proline, proline’s derivatization has been done using fluorescent reagent NBD-Cl. After derivatization, proline has made UV detectable at 465 nm. Within run time of 20 minutes, D and L isomers of proline were eluted at 6.72 and 9.22 minutes, respectively. The technologically advanced method was validated as per ICH guidelines. Linearity regression coefficients for both D and L-Proline are obtained as 0.999. Retrieval for D-Proline was obtained at 93 to 95% range for 4 levels. LoD and LoQ for both D- and L-Proline were detected as 0.6 and 2 ppm, respectively. Hence this method is newer, modest, particular and explicit chiral method.

53. Antitussive Activity of Alcoholic Extract of Piper longum Linn.
Anjali Bedse, Ashwini Nalawade, Pallavi Kamandar, Anita Wagh, Komal Mahajan, Shilpa Raut, Suchita Dhamane
The l-phellandrene and caryophyllene found in Piper longum fruits are effective against a wide range of infections, including stomachic, bronchitis, spleen, cough, tumor, and asthma. This study reports preparing and characterizing alcohol-soluble extract of P. longum L. fruit powder. FTIR spectroscopy and TLC were used to characterize an alcoholic extract of P. longum. P. longum L. alcohol soluble extract was tested for its anti-tussive efficacy using the standard mouse cough model caused by ammonia liquor. Cough frequency was inhibited by 49.51% (Marketed formulation), 50.84% (Extract 100 mg/kg), 62.71% (Extract 200 mg/kg). Statistically significant (p < 0.001) difference was observed in % inhibition of cough frequency of both doses of extract when compared with the marketed formulation. This study reveals an anti-tussive activity of alcohol soluble extract of P. longum L.

54. In-vivo Evaluation of Nephroprotective Activity of Naringenin against ADPKD and MDCK-derived Cysts
T. Naga Varalakshmi, V. Chitra
Aim: Determining the in-vivo assessment of Naringenin’s nephroprotective efficacy against Autosomal dominant polycystic kidney disease (ADPKD) and Madin-Darby canine kidney (MDCK) derived cysts. Method: Our research on the molecular mechanism of naringenin, a flavonoid present in plants and berries that has been shown to limit cell growth and protect against cancer in in-vitro and animal models, was conducted using dictyostelium, a simple, controllable biomedical model. Cultured MDCK cells were used to generate differentiated tubule cells, and these findings were extrapolated to a human kidney model employing these cells. Results: While naringenin inhibited growth in dictyostelium, it had no effect on development. In a random-gene-knockout screen, a TRPP2 (polycystin-2) knockout mutant was discovered to be resistant to naringenin’s effects on growth and random-cell movement. Changes in the divalent transient receptor cause polycystic kidney disease type 2 potential cation channel TRPP2. We found that the growth of cysts and MDCK cells might be inhibited by naringenin. Partial resistance to naringenin was achieved in this model by lowering TRPP2 levels via siRNA, as evidenced by the presence of larger cysts following treatment with 3 and 10 M naringenin compared to controls. Naringenin had no effect on chloride secretion. Conclusion: Naringenin’s influence on cell proliferation is mediated by TRPP2 in both dictyostelium and mammalian kidney cells, despite their vast evolutionary distance from one another (polycystin-2). Naringenin will be the subject of more research as a possible new therapeutic treatment for ADPKD.

55. Preterm Labor with Side Effects: Compare the Effectiveness of Magnesium Sulfate (MgSO4) with Isoxsuprine
Yamini Patil, Padmaja A. Havle, Shivaji V. Raje, Gauri Shinde
Background: In India, 25% of pregnancies develop preterm labor (PTL), resulting in 10 to 69% cases of preterm birth. Medical intervention to stop labor, reduce infection rate, and avoid infant respiratory distress has been the subject of studies for a long time. PTL patients usually get tocolytics, corticosteroids, antibiotics, and other clinically symptomatic and supportive therapy to accomplish this goal. Studies further showed that these tocolytic drugs lower intracellular calcium bioavailability via biochemical pathways, hindering the interaction of actin-myosin. Due to the poor success rate of labor arrest, researchers concluded from their studies that widespread adoption of medical management for PTL has been hampered. The high rate of major side effects of tocolytic drugs, particularly beta-mimetic ones, exacerbated this. We know of no clinical evidence on PTL management in India. Objective: The effectiveness and maternal side effects of MgSO4 and isoxsuprine in PTL arrest. Methods: In our study, we included a total of 82 pregnant women who had PTL discomfort and were admitted to the labor department. Both groups were randomly assigned patients. “Group 1 patients received isoxsuprine hydrochloride, whereas group 2 patients received MgSO4”. After that, a comprehensive clinical examination included vital signs, general, systemic, external genitalia, and PV (per vaginal) results. Investigations include CBC, BT, CT, urine full examination, ABO, RH group, serum electrolytes, RBS, vaginal swab, and Renal function test (RFT). Result: Significant difference (p <0.05) indicated that MgSO4 was more effective. Conclusion: MgSO4 can be used as a tocolytic agent in PTL as it shows better tolerance capacity when compared to isoxsuprine.

56. Preparation and In-vitro Evaluation of Pemigatinib Nanosponges Tablets by Box-Behnken Design
Palanati Mamatha, DVRN Bhikshapathi
Objective: Pemigatinib depicted antitumor action in complex and metastatic tumors and it’s a hydrophobic compound having strong pH-reliant solubility. The current work was designed to improve oral solubility of pemigatinib by incorporating into nanosponges (NSs). Methods: Box-Behnken Design optimized the independent parameters of polystyrene NSs formation. Polystyrene NSs were prepared by ultrasound-assisted method using diaryl carbonate as cross-linking agent, which were later characterized and formulated into tablets. Tablets got screened for the respective quality attributes. Results: A number of tests were carried out from the test runs generated by a three-factor, three-level BBD. The range of mean PS was 153 to 316 nm, the range for encapsulation efficiency% was 68.2 to 91.4%, and the value for PDI was 0.273 to 0.445. ZP for the finalized formula was determined to be -29.1 mV. The drug and excipients were compatible as confirmed by FTIR studies. SEM study confirmed that pemigatinib has successfully entrapped in interior of the polymer. In-vitro examination of the pemigatinib loaded NSs tablets were compared with a marked product and satisfactory results were obtained (98.74 ± 2.65% vs. 93.73 ± 1.06%). The prepared formulations were stable during 6 month stability study period. Conclusion: The study findings for pemigatinib NS tablets demonstrated quick dissolution since the changed solubility qualities of the drug, satisfying the intended objective of increased absorption. Formulated pemigatinib-loaded NSs can be beneficial in the treatment of cancers.

57. Potential Applications of Alpha Nanocellulose from Cow Dung in Biomedicine: A Comprehensive Review
Dharmesh Trivedi, Seema Joshi, Amit Jain3, Sagar S. Jadkar, Rahul I. Jadhav, Gajendra S. Rathore, Anshu Sharma
It is feasible to extract nanocellulose, in particular alpha nanocellulose, from agricultural waste products such as cow dung. This is the case. Nanocellulose of this particular form exhibits unique properties, making it an excellent candidate for biological applications. This review aims to discuss the biomedical applications of cow dung-derived alpha nanocellulose. Nanocellulose has a larger surface area, greater mechanical strength, and better biocompatibility than other cellulose nanomaterials. It starts off by walking through the process of removing nanocellulose from cow manure. Alpha nanocellulose has applications in tissue engineering, the administration of medicines, the healing of wounds, as well as biosensing. Each application is broken down into its component parts, providing insights into the underlying mechanisms, experimental investigations, as well as in-vitro and in-vivo evaluations to establish the viability and effectiveness of alpha nanocellulose. The review paper also discusses the difficulties encountered and the potential future applications of alpha nanocellulose derived from cow dung in biomedicine. These difficulties include the requirement for standardized extraction processes, the optimization of material properties, and the consideration of regulatory issues. This in-depth study demonstrates that alpha nanocellulose that is generated from cow dung is a versatile and environmentally friendly nanomaterial that can be used for medical applications. It is hoped that the findings of this study will inspire more research and creative applications based on the unique properties of alpha nanocellulose, possibly resulting in biomedical breakthroughs by consolidating knowledge and exploring new areas.

58. Resurgence of Human Monkey Pox: A Review
Shilpa Raut, Kajal Baviskar, Komal Mahajan, Shamal Dawange, Mayur Bidkar, Anjali Bedse, Harshal Tare
After being prevailing in Central and West Africa throughout the 1970s, sporadic cases of monkeypox sickness have surfaced in recent years. On the other hand, the monkey pox outbreak in the United States made headlines and garnered international attention in 2003. In 2022, the virus has caused a catastrophic pandemic, with over 50 nations being affected. There were 183 new cases of monkeypox recorded to WHO in April 2023, representing a 0.2% rise in overall cases, and 14 new deaths from the disease. Monkey pox shares the poxviridae family with the smallpox virus. One explanation for the rise of monkeypox in people is the discontinuation of smallpox immunizations. The zoonotic infectious illness is distinguished by a pustular rash resembling smallpox and systemic infection with severity ranging from mild to severe. Though the condition is self-limiting, the consequences it causes can be deadly. The illness has no particular therapy, however, it can be treated using antivirals that are effective against smallpox. Vaccines for smallpox have also been shown to be effective. The current article addresses the signs and symptoms of monkeypox sickness and the transmission pathways and treatment choices.

59. Pharmaceutical Waste Disposal Current Practices and Regulations: Review
Ingale M H, Tayade M C, Patil Y P, Salunkhe R H
The improper disposal of pharmaceutical waste has become an increasingly important environmental and public health concern in recent years. Pharmaceutical waste includes unused, expired, or unwanted medications that can be harmful if they end up in the environment or are improperly handled. This can include prescription drugs, over-the-counter medications, and veterinary drugs. Pharmaceutical waste can be generated by a variety of sources, including healthcare facilities, households, and veterinary clinics. Improper disposal of these medications can lead to water and soil contamination, as well as potential harm to wildlife and humans. In addition, pharmaceutical waste can contribute to the growing problem of antibiotic resistance and other environmental issues. To address these concerns, various disposal methods have been developed to ensure the safe and effective management of pharmaceutical waste. These methods include disposal in the trash, take-back programs, incineration, and landfill disposal. However, there is still a need for improved awareness and education on proper disposal practices among healthcare professionals, patients, and the general public. This review article aims to provide an overview of the current practices and regulations related to pharmaceutical waste disposal and the challenges and opportunities for improvement in this area. Through a comprehensive analysis of the existing literature on this topic, this article will highlight the importance of proper pharmaceutical waste disposal and the need for continued research and policy interventions to ensure a safe and sustainable approach. Our article highlights the importance of proper pharmaceutical waste disposal and the need for improved awareness and education on this topic among healthcare professionals, patients, and the general public.

60. Future Pharmacological Prospectives and Multiple Diagnostic Recognition of Traditional Medicinal Plant Ficus racemosa
Prathamesh P. Khade, Shubhangi B. Sutar, Sachinkumar Patil
A significant medicinal plant called ‘Ficus racemosa’ of the Moraceae species can be found in Southeast Asia, Australia, and India, Mainly in the states of Maharashtra, Gujarat, Uttar Pradesh, Karnataka, and Tamil Nadu. It is frequently referred to as “gular.” Due to the presence of bergenin as a flavonoid, it acts as an anticancer. Numerous isolated active components from various portions of this plant have been discovered to possess advantageous pharmacological characteristics. According to a literature review, it has various pharmacological actions, including liver-protective activity, anti-HIV, antidiabetic, antidiarrheal, antioxidant, antipyretic, anti-inflammatory, antifungal, anticancer and antibacterial activities. This review study does a good job of discussing this particular plant’s traditional usage, phytochemistry, pharmacology, and toxicity.

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