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 Endophytic Fungi in the Kelakai (Stenochlaena palustris) and Their Antibacterial Effect
Harlyanti M. Mashar, Teguh Supriyono, Ismail Ismail, Ysrafil, Dali
The Dayaknese consume Stenochlaena palustris for the treatment of various diseases. The plants contain chemical compounds that have the potential to be developed as antibiotics. This study aimed to isolate endophytic fungi from the leaves and stems of S. palustris, and further identify and assess the isolated endophytic fungi against microorganisms. The research was carried out in several stages, namely, isolation and purification of endophytic fungi, macroscopic and microscopic identification, activity test on isolates, fermentation and extraction of secondary metabolites, and evaluation of the antibacterial activity of the extracts using the disk diffusion method. This experimental laboratory research was conducted in Palangka Raya City, Central Kalimantan, with a test carried out at the Microbiology Laboratory of the Health Polytechnic Ministry of Health, Palangka Raya. The results showed 3 types of endophytic fungi: SpHtm, SpHjk, and Sporn, identified as Aspergillus sp., Paecilomyces sp., and Arthrocristula sp. The antimicrobial effect of the isolated fungi was assessed at various concentrations, i.e., 15, 30, and 45%, against S. aureus and E. coli. The results showed that the ethyl acetate extracts of the SpHtm and SpHjk isolates did not demonstrate any inhibitory response to S. aureus at concentrations of 15, 30, and 45% and did a small inhibitory response to E. coli at an SpHtm concentration of 30% and an SpHjk concentration of 45%, with inhibition zone diameters of 11.63 ± 0.01 and 10.83 ± 0.02 mm, respectively.

2. A Validated, Fast and Simple, Simultaneous Determination of Captopril and Telmisartan in Laboratory Prepared Mixture for Use in Haemodialysis Patients Suffering from Inflammation
Hiren Rana, Richa Dayaramani, Nikunj Patadiya
Captopril and telmisartan are widely used anti-hypertensive drugs, and their fixed dose combination is under phase IV trials. In the present study, spectrophotometry and RP-HPLC methods were successfully developed and validated per standard regulations. In UV spectrophotometry method concentrations of captopril and telmisartan in a synthetic mixture prepared in the laboratory were determined using the simultaneous equation method. The linearity was found 8 to 40 μg/mL for captopril and 5 to 25 μg/mL for telmisartan. The R2 (Coefficient of Correlation) value was found to be 0.999 for both drugs. The %assays of the conc. of captopril and telmisartan in synthetic mixture were found in an acceptable range. In the RP-HPLC method %assay was found to be 100.05 and 100.16% with %RSD value of 0.34 and 0.58 for captopril and telmisartan, respectively. The proposed UV and RP-HPLC method simultaneous estimation of captopril and telmisartan has potential application for qualitative identification as well as quantitative determination.

3. In-vitro Evaluation of Antithrombin and Thrombolytic Activity of Leaves Extract of Lantana camara Linn
Smita Mujbaile, Deepak Khobragade, Dharmenndra Mundhada
Thrombosis is possible outcomes of excessive coagulation or inhibition of anticoagulant processes. The pathophysiology of thrombosis is primarily caused by irregularities of the vascular wall, changes in blood flow, and changes in blood composition. Now a day’s, various natural antithrombotic or thrombolytic medications are used for the treatment. This study evaluated the pharmacognostical, antithrombin and thrombolytic activity of leaves extract of plant Lantana camara. The extractive value of leaves extract of plant L. camara was higher (20.58%) in methylene chloride as solvent. Total ash of plant L. camara was about 9.00% w/w. In comparison with heparin L. camara extract shown 50.10, 60.23, 62.32, 68.48 and 71.32% antithrombin activity at 10, 20, 40, 60, 80 and 100 mg/mL concentration, respectively. When different extract concentrations were added in the tubes containing blood clots, L. camara showed a good thrombolytic activity. We conclude that the leaves extract of plant L. camara shows significant antithrombin and thrombolytic activity.

4. Formulation and Optimisation of Microspheres of Leaves extract of Lantana camara 32 Design Approach
Smita Mujbaile, Deepak Khobragade, Dharmenndra Mundhada
The leaf extracts of plant Lantana camara shows significant antithrombin and thrombolytic activity. Modified release form of extract will show better therapeutics efficiency. In this work the extracts of plant L. camara-loaded polycaprolactone microspheres were prepared using the double emulsion method. 32 design approaches were used for the optimization of polycaprolactone and PVP concentration for response entrapment efficiency (Y1) and drug release (Y2). The microspheres of L. camara were analyzed for EE, FTIR, DSC, XRD and drug release. The entrapment efficiency of L. camara microspheres was in ranges of 62.25 to 84.04%. The particle size of optimized batch of microspheres was 789.6 (d. nm) with PDI 0.838. It shows pH dependant swelling with no interaction between drug and polymer was observed in DSC studies. The % drug release of all thirteen batches was in ranges of 87.91 to 99.04% for 12 hours duration. From the study we conclude the prepared L. camara loaded polycaprolactone microspheres show sustained release action for 12 hours.

5. Validated HPTLC Analysis for Estimation of Quercetin in Seeds of Anethum graveolens
Sukeshini Lote, Surendra Agrawal, Shirin Ghune, Pravina Gurjar
A high-performance thin layer chromatography (HPTLC) method for the quantification of quercetin was developed on methanolic extract of dill (Anethum graveolens) seeds and subsequently validated. A suitable mobile phase was used to establish the HPTLC method, ethyl acetate, toluene, methanol, chloroform, and formic acid (2:3:3:2). A densitometric analysis was done at 366 nm of wavelength. Quercetin has an Rf value of 0.55. In the dilution range of 100 to 800 ng per band, quercetin revealed a linear connection with r2= 0.9938 in the calibration’s linear regression analysis. By conducting replication analysis on 2 separate days and one day, accuracy was verified. The standard addition method was used to conduct recovery studies to validate accuracy. The quercetin recovery rate was 98.60% on average. Five replicates of each of the three standards were used to detect the system suitability parameter. With regard to both the peak area and the Rf value, the %RSD was observed to be under 2%. The mobile phase concentration was altered from Toluene: Ethyl acetate: Chloroform: Methanol (2:3:3:2) to (3:2:2:3) with few drops of formic acid. It was found to have a %RSD of peak area below 10%, the robustness of the method was assessed. The developed HPTLC method was discovered to be easy to use, precise, accurate, suitable, and robust for estimating quercetin from dill seed extract

6. Methacrylic Acid-Acrylamide based ZnO Hydrogel Nanocomposite Assisted Photocatalytic Decolorization of Methylene Blue Dye
Ayad F. Alkaim, Firas H. Abdulrazzak, Shaimaa M. Essa, Usama S. Altimari, Montather F. Ramadan, Aseel M Aljeboree
In this research, preparation of methacrylic acid-acrylamide based ZnO hydrogel nanocomposite (MAA-AM)/ZnO hydrogel nanocomposite by way of co-polymerization via used acrylate acid (AA) (or acrylate salt) (AA) or methacrylic acid (MAA)) and acrylamide (AM). Nanocomposites based on acrylate are characterized via being hydrophilic and able to retain water. Nanocomposite properties were studied using different techniques (FE-SEM, TEM, and EDX). The photocatalytic degradation of methylene blue MB dye under different conditions was studied using nanocomposite like time of irradiation, mass of catalyst (MAA- AM)/ZnO hydrogel nanocomposite, initial MB dye concentration onto photocatalytic degradation and reactivation were studied. The result increases the photocatalytic degradation with the rise weight of catalyst (MAA- AM)/ZnO hydrogel nanocomposite range (0.1–0.25 g). Too, a decrease in photocatalytic degradation was observed with an increase in MB. Observed that after reuse, ((MAA- AM)/ZnO) nanocomposite hydrogel appear photocatalytic efficiency from of the use 1 to 6 cycle 87.88 to 58.87%, showing that ((MAA- AM)/ZnO hydrogel nanocomposite surface appear good stability.

7. Exploring the Potential of Eclipta alba: A Promising Approach for Hair Treatment Management through 5-Alpha Reductase Inhibition
Arpan Chakraborty, Arka Bhattacharjee, Baishakhi Mondal, Manas Chakraborty, Goutam Mukhopadhyay, Maitrish Ghosh, Alpana Majumder
A class of medications known as 5 alpha reductase (5α-reductase or 5αR) inhibitors is used to treat male pattern hair loss and benign prostatic hyperplasia. This study shows that Eclipta alba has 5αR inhibitory action that is helpful in the treatment of androgenic diseases. For 5αR enzyme inhibition evaluation, E. alba was extracted using methanol and petroleum ether. Further phytochemical screening can be done. Phytosterols test negatively found in methanol extract during phytochemical screening but positive in petroleum ether extract of E. alba. HPTLC data of different extracts was performed based on the phytochemical screening found. According to the HPTLC analysis, petroleum ether extract of E. alba contained 0.11% of β-sitosterol, while the methanolic extract had a higher concentration of 4.75%. The inhibitory activity of these plant extracts against 5αR was examined in comparison to the commonly used 5αR inhibitor, finasteride. IC50 measurements for petroleum ether extract of E. alba and β-sitosterol (a chemical biomarker derived from the plant material) were established as 150.76 ± 4.56 and 77.09 ± 3.07 μg/mL, correspondingly. These results indicate their potential as compelling contenders worthy of deeper exploration regarding their anti-androgenic properties. The notable abundance of β-sitosterol in the petroleum ether extract of E. alba enhances its potential for significant biological activity, particularly in terms of inhibiting the 5αR enzyme.

8. Formulation and Evaluation of Punica granatum L Seed Oil-loaded Cosmetic Cream: Its In-vitro Antioxidant Activity
Shrishail M. Ghurghure, Atul A. Phatak
Cosmetic creams for the antioxidant activity of Punica granutum L seed oil (PSO) were formulated in different concentrations of oil in F1 to F6 formulations of cosmetic creams and their physicochemical properties were evaluated. There are several different pharmacological actions attributed to P. granutum L seed oil. The prepared cream was evaluated its properties like pH, resistance to flow, spreadability size, and surface charge value, and ex-vivo release study were performed. All results are found within the limit and it complies with the specification as per requirements. Good in-vitro DPPH scavenging activity was observed from the optimized batches throughout the preparation. To determine the stability profile, cosmetic creams containing PSO (Batches F1 through F6) were exposed to a three-month accelerated stability study in accordance with ICH recommendations. From this study it was concluded that prepared batches used for various treatments of skin disorders.

9. Developed and Validated RP-HPLC Method for Concurrent Analysis of Some Cardiovascular Drugs
Vijaykumar Pawar, Harinath More
Objective: An ICH-compliant RP-HPLC approach was created and validated in order to measure the concentrations of HCTZ and LIS in bulk and mixed medicinal dosage forms. This procedure was subsequently submitted for certification. Methods: Column, a Phenomenex Luna C18(2) (250 x 4.6 mm, 5μ) with a Methanol: Formic acid (30:70) mobile phase, a flow rate is kept as 01 mL/min, the wavelength of detection was 215 nm, and a used detector was PDA. Results: Hydrochlorothiazide (HCTZ)) and lisinopril (LIS) both had linear calibration curves (r2 = 0.9973 and 0.9983, respectively) for the ranges of concentration 4.0 to 6.0 and 10.0 to 15.0 μg/mL. The proposed technique eluted LIS in 3.97 minutes and hydrochlorothiazide in 4.53 minutes. Lisinopril had a recovery rate of 99.31 to 99.83%, whereas hydrochlorothiazide had a recovery rate of 100.75 to 101.16%. At 1.22 and 0.31 μg/mL, respectively, HCTZ as well as LIS had the lowest detectable values. It was found that the LoQs for lisinopril and hydrochlorothiazide were 0.97 and 3.75 μg/mL, respectively. Conclusion: It was found that the current RP-HPLC technique is reliable, simple to use, accurate, linear, efficient, and rapid. With a shorter analysis period, this method offers better resolution between the two compounds. Therefore, there is sufficient evidence to include the approach in regular lisinopril and hydrochlorothiazide analysis in a variety of pharmaceutical companies and academic institutions.

10. HPLC Method Validation for Quantification of Lisinopril
Vijaykumar Pawar, Harinath More
This study aimed to develop a straightforward, sensitive, exact, quick, and accurate reverse phase high performance liquid chromatography (RP-HPLC) method for figuring out how much lisinopril is in pharmaceutical gels and other large amounts of medication. Agilent Zorbax Bonus-RP column (250 x 4.6 mm, 5μ) was used for the chromatographic separation. “A mobile phase composed of methanol and trifluoroacetic acid (50:50 v/v) was used to develop the analytical procedure. The flow was found to be occurring at a rate of 1-mL/min and with a wavelength of 215 nm. The retention time was 2.28 min. In a concentration range from 3–7 μg/mL (r2=0.998), the drug’s response was determined to be linear. The LoQ was 1.11 μg/mL, while the LoD was 0.36 μg/mL. Lisinopril’s %assay was determined to be 98.22%, while assays for the other medicines in the commercial formulation showed no interference from the excipients. This method functions well and can be applied to routine analysis.

11. Synthesis and Characterization of Hydroxypropyl Sesbania Galactamannan Seed Gum for Pharmaceutical Application
Vivekanand Chatap, Ganesh Choudhari, Prashant Jain, Mahesh R. Bhat
The core focus of current research is chemical polysaccharide modification in pharmaceutical applications. The gum is made from the endosperm of Sesbania grandiflora Plant seeds that belongs to family Leguminosae. Both water-soluble and water- insoluble gum were present in the Sesbania seed powder; the water-soluble gum was removed during purification, yielding a 30% purification yield. In order to increase the applications of partially hydroxypropyl Sesbania gum, the modifications indicated here entail adding hydroxypropyl groups to the molecule under a variety of different conditions. Among the factors that were looked at were the etherifying agent concentration, alkaline volume, and preparation medium parameters, including the reaction time and temperature. The degree of substitution (DS) was raised, which boosted the unaltered gum’s solubility, stability, and viscosity. Increases in an etherifying agent and alkali concentration, volume, reaction duration, and temperature increase DS from 0.4 to 0.7. The finished product was characterized using IR spectroscopy, differential scanning calorimetry, X-ray diffraction, scanning electron microscopy, rheologic property, solubility, swelling index, and gel fraction analysis of batch F1 as an improved batch. The alternate method for developing drug-loaded nanoparticles for controlled release dosages form by suing hydroxypropyl Sesbania gum.

12. Isolation and Identification of Phenolic Profiles in Selected Himalayan Wild Berries and Determination of their Antimicrobial Activity
Preeti Bhadauria, Kamal S. Rathore
A fundamental source of food and medicine for nearby Himalayan populations is the diversity of plants. The percentage yield of extract, phytochemicals, and minimum inhibitory concentration (MIC) for the extracts Euterpe oleraceae, Vaccinium myrtillu, Phyllanthus embilica, Rubus ellipticus, and Rubus niveus were determined. The clinical and laboratory standards Institute’s micro broth dilution method was used to assess these extracts’ antimicrobial effects on Klebsiella pneumoniae and Pseudomonas aeruginosa, while the purification of the positive extract was done by high-pressure liquid chromatography. Phytochemical analysis was done to determine the secondary plant metabolites, including alkaloids, polyphenols, glycosides, tannins, flavonoids, carbohydrates, steroids, and saponins. All five of the studied plants’ extracts showed antibacterial activity against one or more tested microorganisms. Several phenolic acids (chlorogenic acid, salicylic acid, ellagic acid, ferulic acid, gallic acid, and caffeic acid were detected in all extracts. The R. ellipticus extracts with petroleum ether, chloroform, methanol, and water show a maximum yield between (64–56%) except R. ellipticus extract with hexane (25.82%) showed a low yield. All the extracts have major quantities of carbohydrates, flavonoids, and phenols. These results suggested that produced antimicrobial activity was due to the presence of phytoconstituents in all extracts.

13. Prevalence of Stress Among Health Professionals During COVID-19 Pandemic in The UAE: A Cross-sectional Study
Sonal L. K. Budihal, Shatha A.Sharbatti
A cross-sectional study was conducted among full-time health professionals of both genders who agreed to participate and sign the consent form. A self-administered, standardized, work-related stress (WSQ) and perceived stress (PSS-10) questionnaire were used. In addition, information on socio-demography, general health, and work characteristics was obtained. Data was analyzed by SPSS version 27. The Chi-square test and logistic analysis were used. Results: The prevalence of moderate/high stress was 90%. The greatest prevalence of high stress was found among older compared to younger professionals [8.6 vs.7.5%, p=0.004], females compared to males [8.1 vs.7.8%, p=0.006], specialist/consultant compared to nurses and medical practitioners [9.7, 8, 2.6%; p=0.01]. Working > 48 hours/ week compared to ≤ 48 hours/week [8.6 vs. 6.3%, p=0.005], have chronic disease compared to No chronic disease [ 8.2 vs. 7.8%, p=0.04]. The percentage of stress in the following work domains: low influence at work; work interference with leisure time; items in “Indistinct Organization and Conflicts” and “Demands and commitments” were: 13, 70.3, 12.1 and 16.3%, respectively. Logistic analyses showed that gender and age significantly predict a high-stress level. Conclusion: The present study showed a high prevalence (90%) of moderate- to high-stress levels. Age and gender were significant predictors of high-stress levels among healthcare professionals. The most frequent work-related stress factor was work interference with leisure time (70.3%).

14. Preparation, Optimization, Compatibility Study of Captopril Proniosome, and In-vitro, In-vivo Evaluation of Release Study
Vaibhav L. Narwade, Namrata Singh
Coagulation compartment isolation technology has also developed transdermal proteosome arrays using various non-ionic surfactants. Span-60 proteasomes have reduced HLB values, longer chains alkyl, and high transition temperatures, resulting in higher capture efficiency (84.14 ± 4.76). The addition of cholesterol LDL and lecithin also increased bilayer stiffness. The size of the vesicles decreases with his Tween method and multiplies with wingspan and consciousness. Low polydispersity index and high zeta capacity were observed in the arrangement of proteasomes. TEM studies confirm perfectly round niosomes. Infrared studies have confirmed that the vesicular form has no drug interactions and no drug is trapped. Proniosomes demonstrated slower release kinetics than controls. Captopril in 40% PEG. Additionally, the defined emission charge of span changes compared to Tween, which can be attributed to the lipophilicity of span and captopril. The release profile was observed for the Higuchi version, suggesting that drug introduction is diffusion controlled. The transdermal flux of captopril was highest for the span 60 system in isolated and closed rat skin.

15. Synthesis, Characterization and Biological Evaluation of Glycogen Synthase Kinase-3β Inhibitors as Antidiabetic Agents
Ankit Mangal, Neelesh Malviya
Diabetes is a substantially growing unhealthiest in the globe that causes severe morbidity and mortality. Currently a day’s there’s an imperative for the invention, development and improvement of novel antidiabetic drug molecules. A chain of compound (5-imidazol-2-yl-4-phenylpyrimidin-2-yl) [2-(2- pyridyl amino) ethyl] amine were developed and synthesized by using suitable chemical synthetic techniques. These recently synthesized derivatives were characterized with the help of modern analytical techniques. This compound was evaluated for glycogen synthase kinase-3 enzyme inhibitor activities for managing of polygenic disease. GSK-3 inhibitors may advance and emerge as a novel strategy for the management of diabetes.

16. Development and Validation of HPLC Method for Estimation of Some Active Analytes in Combined Dosage form an Application to In-vitro Dissolution Studies
Mayuri N. Deshmukh, Vaibhav P. Uplanchiwar, Vinod M. Thakare, Namrata S. Mane, Sanjana N. Gaikwad, Narendra R. Dighade, Hina D. Mehta, Ravi Bakal, Prashant Umate
This paper describes a new, simple, accurate and economical method of development and validation of HPLC method for the assessment of dicyclomine hydrochloride with omeprazol magnesium combine dosage form. The method development trial was carried out initially using C8 (100×0.46×3.5 μm) and C18 GraceSmart (250×4.6×5 μm) as stationary phase and acetate buffer (pH 4.5) and methanol as mobile phase in proportion 60:40v/v. The optimized conditions of factors were sample size 50 μL and wavelength (λmax) 215 nm. The developed method was then applied to in-vitro dissolution studies for the dicyclomine hydrochloride and omeprazole magnesium. As per ICH guidelines, stability testing was done. The estimated method can be used to analyze the pharma industries’ products.

17. Phytochemical Evaluation of Extracts and Pharmacological Activity of Polyherbal Emulgel
Jitendra Kandale, Jaiprakash Sangshetti, Paresh Mahaparale, Ganesh Dama, Jayant Bidkar
Ocimum sanctum, Rubia cordifolia, Glycyrrhiza glabra, and Punica granatum are all used to treat various diseases and conditions in Ayurvedic medicine. In this study, we aimed to formulate and evaluate a polyherbal emulgel containing extracts from four different medicinal plants: O. sanctum, R. cordifolia, G. glabra, and P. granatum. Different gel formulations were created by combining a base component with extracts from O. sanctum, R. cordifolia, G. glabra, and P. granatum. pH, viscosity, rheology, appearance, and homogeneity were some of the criteria examined for each formulation. They were tested for evaporation and irritation of the epidermis with patches. The cup plate method was used to examine the antibacterial-antifungal activity of formulations against Escherichia coli, Pseudomonas aeruginosa, and Aspergillus niger. Results showed that the inhibition zones produced by all formulations were greater than those produced by the control. Antimicrobial characteristics can be found in polyherbal gels. Synergy between the plant components in the blend produced the desirable outcome.

18. Investigation of the Effects of Chia-fortified Basisa on Diabetic Patients
Wedad M. A. Manjil, Muna A. Ilowefah, Hanen B. Ismail, Hussein L. Algboory
It suggested that phytochemicals found in cereals, legumes and chia possess several health effects. Consequently, this study aimed to investigate the influences of chia-fortified basisa on type II diabetes, total cholesterol and triglycerides. Urea, creatinine, blood pressure and body mass index were also determined. Basisa is a cereal-legumes food that were prepared using wheat, chickpea, lentils, fenugreek, turmeric and cumin in measured ratios. Chia powder was added to basisa by 5 and 10%. The participants were diabetic (type II) with cholesterol and triglycerides elevation. They were divided into three groups according to the chia powder (0, 5 and 10%) used. The study were conducted for 90 days. The results indicated that groups who had basisa with chia had significantly (p ˂ 0.01low levels of HbA1c, cholesterol, LDL, triglycerides, BMI and blood pressure compared to the control groups after 90 days of the study. Urea and creatinine levels were increased; however, their levels were still in the normal range. It can be concluded chia powder enhanced the positive effects of basisa on chronic diseases and obesity.

19. A Validated Sensitive Stability Indicating HPLC Method for the Determination of Etoricoxib in Bulk and Formulation
Khushabu Patil, Swapnal Narkhede, Mahesh Nemade, Sachin Rane, Rajesh Chaudhari, Gayatri Dhobale, Harshal Tare
Aim: The current research aims to create a high-resolution and validated liquid chromatographic method used for quantitative detection of etoricoxib within dosage forms that is both easy to use and reliable in terms of accuracy, sensitivity, and reproducibility. Materials and Methods: Analysis was carried out at isocratic conditions at flow rate of 0.7 mL/min using a mobile phase consisting of 40 parts methanol to 60 parts water (0.1% OPA) at pH 3.2. The eluents were tested using UV detection at 236 nm. Results: Etoricoxib had clearly separated peaks with a retention duration of 4.347 minutes in the optimized settings. The concentration range used to generate the calibration curve was 10 to 60 μg/mL. LoD was 0.0779 μg/mL, and upper LoQ was 0.23 μg/mL. The approach has been effective in separating a known quantity of etoricoxib, and the percentage of degradation was shown to be very low across all stress settings. Conclusion: Etoricoxib in bulk drug and commercial formulations can be identified and quantified using the proposed method, which has been validated in accordance with ICH recommendations.

20. Design, Development and Characterization of Econazole loaded Nanoparticles for Topical Application
Sufiyan Ahmad, Khushabu Patil, Ganaraj Koli, Bakhshi A. Rahman, Lokesh Barde, Mahesh Deshpande, Harshal Tare
Background and Objectives: Econazole nitrate (ECN) loaded nanoparticles with topical administration were the focus of the current study, which aimed to improve the topical efficacy of the medicine in treating fungal infections while also mitigating the drug’s gastrointestinal (GI) side effects. Further colloidal carrier methodology was employed as a method for the topical administration of medications with precision. Method: The emulsification-diffusion (E-D) method is an alternate approach for preparing nanogels that avoids the toxicity- solvent issues associated with the emulsification-evaporation technique. Its ease of use, enhanced stability, and adaptability have all been verified by a variety of research groups. ECN loaded with dichloromethane in stabilizer solution, formulated by high-speed homogenization at elevated pressure. The addition of aqueous phase with repeated homogenization cycles causes drug diffusion into nanogels. Further addition of mannitol as cryoprotectant and Carbapol 940 as gelling agent stabiles the formulation. Results: The typical size of the particles, polydispersity index (PDI), and zeta potential were all measured with the use of the Malvern zetasizer. Of the five NFs, the lyophilized batch of NF3 exhibited the lowest zeta potential (-11.6 mV) and the PDI (0.208), indicating that the composition was stable. DSC and XRD analysis revealed an amorphous transformation of ECN. The scanning electron micrograph demonstrated discrete, roundish particles. The existence, viscosity, and spreading ability of a gelled dispersion of the selected NLCs were evaluated. Total od 77% of the medication was released in-vitro from a chosen formulation of ECN-loaded nanogels. As a result, it is reasonable to assume that ECN-loaded nanogels are an effective drug delivery system for treating fungal infections since they prolong the duration of drug release. Conclusion: Under degraded conditions, there are not any peaks that conflict with one another. As a result, a technique was developed that is highly applicable due to its sensitivity, strength, accuracy, and demonstration of stability.

21. Design and Development of Analytical Method for Deflazacort Estimation: A Robust HPLC Approach
Swati Pund, Vaibhav Changediya, Vikas Rajurkar
The data show that the RP-HPLC method can accurately determine the amount of deflazacort (DEF) in compound. Validation of procedure followed ICH standards. The wavelength of estimation for deflazacort was 266 nm. Linearity was found to be 20 to 100 μg/mL for deflazacort. The %recovery for deflazacort was found to be 80 to 120%. Intraday precision of deflazacort was found to be 0.069 to 0.168% RSD. Interday precision found to be 0.0156 and 0.176% RSD.

22. Implementing of Nursing Intervention on Knowledge, Perceived Stigma and Health related Outcomes among Patients with Hepatitis B Virus
Nabila E. Sabola, Shereen Hussien, Azziza Kamel, Marwa A. Elsalamony Marwa A. Shahin, Lamiaa A. Ali, Samia A. Loulah
Background: Despite significant advances in the therapy components for hepatitis B virus (HBV) prevention and treatment, HBV-related stigma is seen as a major barrier to HBV management. The HBV-related health stigma has a direct negative impact on the process of healthcare delivery and medical decision-making. The study aimed to evaluate the effect of implementing the nursing intervention on knowledge, perceived stigma and Healthrelated outcomes among patients with hepatitis B Virus. Subjects and method: A quasi-experimental (pre -posttest) study research design was used. Study setting: The present study was carried out at Menoufia University Hospital (in-patient medical department) and well as in the out-patient medical department after patients discharge and followed up. Sampling. A purposive sample of 50 adult patients who were diagnosed with HBV virus. Results: The total mean knowledge score was significantly improved post-intervention than pre-intervention among studied HBV patients. The mean of hepatitis B stigma level reduced post-intervention. There were statistically significant improvements among studied patients’ related to some of abdominal, activity, and systemic symptoms post-intervention. There was a significant improvement for serum total bilirubin and serum ALT among studied patients post-intervention. There was a reverse correlation between hepatitis B knowledge and hepatitis B stigma post-intervention. Conclusion: Implementing a nursing intervention significantly enhances patient knowledge, lowers perceived stigma level and improves health-related outcomes. Recommendation: Establish periodic public awareness campaigns emphasizing hepatitis B virus transmission methods to discover new cases and control infection.

23. Biosynthesis of Silver Nanoparticles using Annona squamosa L Seed and Leaves Extract: Evaluation of the Anti-inflammatory, Antifungal, and Antibacterial Potency
Yogesh Kolekar, Firoj Tamboli, Dinanath Gaikwad, Shabana Memon, Sampada Gulavani, Kamal Alaskar, Dipak Mali, Vijaykumar Pawar
Creating efficient therapeutic techniques against multi-drug resistant pathogens is crucial in the age of rising bacterial resistance and infectious disease outbreaks. In this case, Annona squamosa seed and leaf extract were used to create silver nanoparticles, which were then assessed using various characterization techniques, including UV-vis scanning electron microscopy, X-ray powder diffraction, particle size, and Fourier-transform infrared spectroscopy. The synthesized AgNPs were tested for their ability to combat a variety of gram-positive and gram-negative bacteria as well as their ability to control free radicals and inflammation brought on by skin damage caused by microbial infection. AgNPs from seeds have a greater effect than those from leaves, so they were used to create several batches of gel formulation utilizing different gelling agents such as HPMC, chitosan, and Carbopol. Gel was also evaluated for its physical characteristics, including color, clarity, pH, viscosity, spreadability, and extrudability. It also underwent a centrifugation test and a drug release test. Since the F6 batch outperformed the other batches in the evaluation test, it was chosen to evaluate the antibacterial and antifungal activity.

24. Formulation and In-vitro Evaluation of Bilayer Tablet of Olmesartan Medoxomil for Biphasic Drug Release
Tarun Parashar, Kapil Kalra, Jyoti M. Kalra, Nishan Singh, Supriyo Saha, Alka Singh, Sristhi Morris, Vikash Jakhmola
Objective: The current study aimed to optimize the bioavailability and absorption of olmesartan in the lower gastrointestinal tract by creating a bilayer tablet for biphasic drug release. Methods: Microcrystalline cellulose was combined and direct compression the requirement for an early response to address an undesirable defect or condition. In the current instance, 5 mg of olmesartan must be released immediately, and the remaining 10 mg of olmesartan must be released gradually to maintain the therapeutic concentration. In order to adjust the release pattern of the olmesartan sustained release tablet in accordance with the needs of therapy and IP guidelines. Result: The best cumulative drug release was demonstrated by formulation. All formulations for immediate release support the first-order kinetics. As a result, all three formulations were chosen for additional research. Dissolution rate for long-term release Cumulative drug release from the SR1 to SR3 formulations using HPMC K15M and gum acacia was up to 24 hours. Utilizing HPMC K15M and guar gum, the formulations SR1, SR2, and SR3 demonstrated cumulative drug releases of 72.66, 69.19, and 92.66%, respectively. The best cumulative release of the drug was demonstrated by formulations SR1, SR2, and SR3. Consequently, everyone was chosen for additional research. The cumulative drug release for the IR1-SR1, IR2-SR2, and IR3-SR3 bilayer tablet formulations was 95.24, 90.15, and 91.09%. Up to 12 hours of cumulative drug release from the formulation was observed. As a result, it was determined that IR1-SR1 was the best formulation out of all of them due to its strong correlation between the total cumulative percentage of medication releases and time, which was 95.24% up to 12 hours.

25. Development and Validation of HPLC And HPTLC for Simultaneous Analysis of E and Z Guggulsterone, A-11–KBA And 11–KBA from Herbal Formulation
Sufiyan Ahmad, Aakanksha Dashpute, Mukesh Patil, Manish Bhise, Lokesh Barde, Kranti Musmade, Harshal Tare
RP-HPLC and HPTLC are two easy, sensitive, efficient, and accurate procedures that allow for simultaneous estimates of Z and E guggulsterone, A-11-KBA, and 11-KBA. For the HPLC method, we recommend the use of a symmetry C18 column. Using a solvent gradient based on solvent A (orthophosphoric acid) and solvent B (methanol), the effluent was monitored at 250 nm with a 1.0 mL/min flow rate. The peaks of 11-KBA and A-11-KBA were eluted at 5.8 and 6.3 minutes, while those of Z and E-guggulsterone were at 4.8 and 5.3 minutes. For the HPTLC method of separation, a silica gel layer was applied on an aluminum plate prewashed in methanol using a Camag Linomat V applicator fitted with a 100 μL syringe. The linear expansion was carried out using a solvent mixture of n-hexane, chloroform, ethyl acetate, and methanol (v/v/v: 10:3:3:1, respectively). Camag T.L.C. scanner III (V, operating in reflectance-absorbance mode at 254 nm and controlled by win CATS software, was used to carry out the densitometric scanning. The R.F. resolutions for 11-KBA, A-11-KBA, E-guggulsterone, and Z-guggulsterone in the selected mobile phase were 0.68, 0.61, 0.39, and 0.28, respectively. The linearity, accuracy, and precision of the techniques were all confirmed. The proposed methods were successful in estimating E- and Z-guggulsterone as well as 11-KBA and A-11-KBA.

26. Videodermoscopy Evaluation in Non-scarring Alopecia of Scalp
Gaurav Rajauria, Sarita Jangra, Lokesh Barde, Kranti Musmade, Shaima KA, Bhupinder Bhyan, Cheppalli Vani, Vineetha S, Rajasree S, Harshal Tare
Introduction: Hair is a versatile structure, and its importance has been linked to it in the beautification of human beings for ages. According to studies on the psychological impacts of androgenetic alopecia (AGA) in men, they are older, weaker, and less appealing. Hair loss in women gives significant stress and lowers self-confidence. Aim: To perform videodermoscopic findings in non-scarring alopecia of scalp versus control volunteers. Material and Methods: Total of 140 patients satisfied the study’s inclusion criteria after a general medical examination, scalp examination (including inspection of the hair shaft and root), and hair anchoring and fragility tests. We examined the lesions with a videodermoscopy, took images, and wrote up our findings. Results: The study found that patients averaged 26.85. Onset averaged 25.15 alopecia averaged 10.3 months. Our sample had 87.7% spotty AA. Conclusion: Videodermoscopy is an effective non-invasive tool of considerable potential in dermatological practice. It is becoming popular as a hair loss differential diagnosis tool.

27. QbD Approach for Analysis of Tirzepatide in its Bulk and Marketed Formulation by Stability Indicating RP-HPLC
VM Goud, P. Sirisha, Rachana K. N, Ramreddy Godela, Beda D. Prasad
The core intentions of the stated work has been to create and validate a simple, sensitive, specific, precise and cost-effective RP-HPLC method with good performance for the investigation of tirzepatide in API powder and its marketed formulation. HPLC system (WATERS) equipped with DAD detection system was used to develop the current system. The procedure conditions of BDS C18 (150 x 4.6 mm,5 m), 0.01N KH2PO4: Acetonitrile in the ratio of 41:59 (% v/v), a flow of 0.9 mL/min, and a temperature of 31°C were successfully optimized by central composite design of QbD experiments. The optimized wavelength selected was 250 nm. RT of tirzepatide was observed to be 2.841 minutes with good system suitability. The ICH Q2(R1) standards functioned as a validation for the planned action strategy. Linearity was observed for 5 to 30 μg/mL concentration series of tirzepatide with R2 of 0.999. The %RSD results of both precisions were found in the range of 0.40 to 0.41.% recovery of Tirzepatide in spiked samples was assessed to be 99.89%. The LoD and LoQ of tirzepatide were calculated to be 0.05 and 0.14 μg/mL, respectively. The results assured that the established procedure was simple, sensitive, specific, accurate and cost- effective. Exploration of tirzepatide under a diversity of FD conditions represents the stability representing the quality of the established HPLC procedure. Hence, the anticipated process has significant credit in the pharmaceutical segment.

28. Nutritional Significance of Benincasa hispida
Aryan Aggarwal, Luxita Sharma, Dhananjay Sharma, Shankar Dhobale, Nitin Deshmukh, Lokesh Barde, Harshal Tare
Ash gourd is sometimes known as wax gourd, and it’s scientific name is “Benincasa hispida,” also known as B. cerifera, and it is from the family- Cucurbitaece. B. hispida is said to be originated from Japan and Java, but it was widely cultivated in warm climates. It is one of the most well-known crops, farmed largely due to its fruits, and is known for its nutritional and therapeutic benefits, particularly in Asia. It’s a famous vegetable crop that was used both for nutrition and medicine. Volatile oils, flavonoids, saccharides, glycosides, vitamin, proteins, ß-sitosterin, minerals, carotenes, and uronic acid are among the major constituents of B. hispida fruits, according to phytochemical analysis. According to pharmacological studies, the pharmacological activities of this plant included central nervous effects (muscle relaxant, anxiolytic, antidepressant, in the Alzheimer’s disease treatment and to reduce opiates withdrawal symptoms), antioxidant tanalgesic, antiasthmatic, diuretic, antiinflammatory, hypolipidemic, antidiabetic, nephroprotective, and antimicrobial. B. hispida’s chemical constituents and pharmacological effects were highlighted in this review. This paper discusses the cultivation, nutritional and chemical content, as well as the medical and therapeutic properties of this versatile fruit as one of the potential sources of bioactives for functional foods, among other topics.

29. Data Integrity Violations in the Pharmaceutical Industry and Regulatory Measures
M H Ingale, M C Tayade, Y P Patil, Rahul Salunkhe
Data integrity is critical to the pharmaceutical industry, ensuring the reliability, accuracy, and consistency of data generated throughout the product lifecycle. However, data integrity violations have been a growing concern, potentially compromising pharmaceutical products’ safety, efficacy, and quality. This systematic review aims to provide an overview of data integrity violations in the pharmaceutical industry and examine the regulatory measures implemented to address this issue. Through a comprehensive analysis of literature, this review highlights the root causes of data integrity violations, the impact on patient safety and public health, and the regulatory landscape governing data integrity in the pharmaceutical industry. It is essential for pharmaceutical companies to prioritize data integrity as an integral part of their operations, from research and development to manufacturing, clinical trials, and post-marketing surveillance. By implementing robust data integrity practices and adhering to regulatory requirements, pharmaceutical companies can protect patient welfare, maintain regulatory compliance, and sustain public trust in the industry.

30. The Nutritional Needs of Mothers and Babies: A Review
Sanjana Joshi, Luxita Sharma, Lokesh Barde, Manoj Tare, Dwarkadas Baheti, Ganesh Dama, Harshal Tare
The aim is to assess the importance of measuring healthy habits by pregnant women, that enhance different factors of mother and fetus health. We evaluate the change and variations in dietary recommendations. A female went through a lot of physical and mental changes in different stages of pregnancy and there are some common symptoms such as vomiting, fatigue, nausea, frequent urination, dizziness, etc. Certain hormonal changes are there to balance the body’s fatigue, tiredness, and hormones, few dietary recommendations are mentioned and it has been concluded that diet plays an important role during pregnancy, and meeting all the nutrition needs is an essential factor in planning the diet. Many diseases/deficiencies are there such as goiter, iodine deficiency, folate deficiency, gestational diabetes mellitus, gestational weight gain, Neural tube defects, and much more. A detailed view is mentioned below in the following paper: On average, pregnancy lasts 40 to 42 weeks (Nine months). On average, weight gain for a pregnant woman is 12 to 14 kg, thus weight gain can lower the risk of complications during labor and also lower the risk of LBW (low birth weight). Low GWG increases the risk of having an LBW infant. The average weight of the baby should be 2.5–3 kg. A baby having this much body weight should be considered a healthy infant. We provide up-to-date advice for achieving optimal nutrition before conception, throughout breastfeeding, in the first two years of life, and for preschoolers, with an eye on long-term health benefits. These guidelines are intended to aid in the primary prevention of obesity and the non-communicable diseases it is linked to among economically privileged groups, such as European women and children. Medical professionals should be incentivized and educated to promote and advise patients on preconception nutrition, which includes enhancing adolescent nutrition and health. Women who are physically active, eat healthily, don’t smoke, don’t drink excessively, and have a good body mass index (BMI) have a higher chance of having a safe pregnancy. Women of childbearing age should have their consumption and status of specific micronutrients closely monitored, especially folate. Women at risk for insufficient dietary intake of certain micronutrients may benefit from taking dietary supplements containing iron, vitamin D, vitamin B12, iodine, and maybe others. Smoke and alcohol should be strictly eliminated from the diet. Yes, diet plays an important role during pregnancy but staying physically active is equally important for the mother and the baby to promote general health and well-being. Exercise and stretching can reduce the risk of excessive maternal weight gain or gestational weight gain(Obesity). A long walk can greatly help a pregnant woman after lunch or in the morning.

31. Harnessing the Power of AI in Pharmacokinetics and Pharmacodynamics: A Comprehensive Review
Vijaykumar Pawar, Abhinandan Patil, Firoj Tamboli, Dinanath Gaikwad, Dipak Mali, Anilkumar Shinde
Personalized medicine, medication discovery, and development might all benefit greatly from AI’s incorporation into pharmacokinetics and pharmacodynamics. Target identification, therapeutic effectiveness prediction, drug design optimization, obstacles, and future possibilities are all explored in this survey of AI applications in these areas. An overview of pharmacokinetics and pharmacodynamics is presented first, stressing the significance of knowing how drugs are absorbed, distributed, metabolized, and excreted and the correlation between drug concentration and pharmacological effect. The article then looks into the function of AI in target identification, exploring how machine learning algorithms and data integration may be used to discover new drug targets and enhance the design of existing ones. Classification and regression methods are also investigated for their potential use in the prediction of therapeutic efficacy using AI. Patient data, molecular interaction data, and clinical response data are just a few examples of the types of data that may be used to fuel the creation of predictive models that might assist in dosage and efficacy optimization. Metrics and procedures for validating these models are addressed to evaluate their efficacy. Additionally, de novo drug design, virtual screening, and structure-based drug design are all discussed in relation to the use of AI in optimizing drug development. The paper provides examples of how AI has been applied successfully in different settings, demonstrating its potential to hasten the drug discovery process and enhance treatment outcomes. We examine data availability, interpretability, and ethical implications as challenges and limits of AI in pharmacokinetics and pharmacodynamics. To guarantee these technologies’ proper and ethical use, we also discuss the regulatory elements and rules for applying AI in drug research. Possibilities and prospects for the use of AI in pharmacokinetics and pharmacodynamics are discussed as a conclusion to the review. It stresses the significance of regulatory standards and clinical translation, as well as the incorporation of multiomics data, deep learning methods, real-time monitoring, explainable artificial intelligence, collaborative networks, and more.

32. Traditional Herbal Medicines As a Complementary Treatment for Monkeypox
Pooja Sahu, Divyansh Sharma, Deepak K. Dash, Vaibhav Tripathi, Rakesh Tirkey, Harshal Tare
Background: Since May 2022, that has been largest-ever spread of monkeypox in countries where it is not normally found. Since India is home to about 36% of the world’s population, an MPXV outbreak there might have far-reaching consequences. A fuller understanding of the monkeypox virus and the epidemiology of the disease is urgently needed to help clinicians, public health professionals, and politicians be prepared for any eventuality, especially given the speed with which it has spread to non-endemic nations. Aim: Review provides an overview of the epidemiology, clinical characteristics, treatments, vaccinations, and herbal resources used in the management of infection for the monkeypox disease. Immune-compromised host & group require to be given additional notice as the illness is known to have significant effects on pregnant women; we have also highlighted relevant information about such pathophysiological situations in this work. Result and conclusion: The spread of monkeypox virus (2022) in non-endemic nations could provide India with an opportunity to investigate the Krimighna medications mentioned in Brihatrayee, i.e. Charak Samhita, Sushruta Samhita and Ashtanga Hridaya with antiviral activity and to develop novel and useful antiviral agents to combat the monkeypox menace effectively.

33. Horse Chestnut Seed Extract: An Opportunity for Creating Evidence- based New Natural Products
Poonam N. Chougule, Kailasam Koumaravelou, Nilesh B. Chougule
For centuries, herbal remedies have been used to prevent and treat disease. Horse chestnut seeds are an abundant source of phytoconstituents containing triterpenoid saponins, with thirty molecules isolated and characterized. Escin, which is a combination of acylated triterpene glycosides composed of α- and β-escin, is the major biologically active component of horse chestnut seed extract. Escin is the most researched veno-active compound with anti-inflammatory, anti-oedematous, and antioxidant properties. Due to their unique three pharmacological actions, escin is a well-established molecule for the management of venous diseases such as chronic venous insufficiency (CVI) and hemorrhoids. The available treatments for CVI have some disadvantages, including severe side effects, expensive surgical options, long duration of treatment, and limited accessibility to allopathic drugs. As a result, phytoconstituents and lifestyle changes can be seen as safe and effective therapy options for CVI management because they have no major side effects and can simultaneously function on several targets. This review article focuses on the chemical components of horse chestnut extract, particularly the phytoconstituents escin, and proanthocyanidins, which have been extensively studied in preclinical and clinical studies. The review article provides a comprehensive overview of their potential therapeutic benefits in managing symptoms of CVI and their regulatory status.

34. An Updated Overview on Personalized Medicine: The Next-Gen Paradigm
Himanshu Sharma, Urmi Bhadouria, Teenu Sharma, Arindam Chatterjee, Parveen Kumar
Personalized medicine is a translational approach that utilizes an individual’s genetic profile to guide illness prevention, diagnosis, and treatment choices. The human genome project data is being used to enhance personalized treatment. “Personalised” medicine is beneficial over “individualized” medicine as it suggests that future hazards may be predicted based on the individual’s genes. The advancement of technology for personalized medicine depends heavily on standardization, integration, and harmonization. The scientific practices at various research sites, the connection between science and healthcare, and the relationship between science, healthcare, and broader society, including the legal and ethical paradigms, the dominant cultural and political ethos, and the expectations of patients and citizens – all need to be in harmony. There are several descriptions of the current existing legislation that regulates genetic screening and genomic medical services in various countries around the world, highlighting discrepancies and specifying areas of law where harmonization may be needed to enable the use of individually tailored medication globally. The promise of personalized medicine can only be fulfilled by placing the individual at the centre of personalized medicine and tailoring care to each patient’s unique psychological and social needs in addition to their biological profiles.


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