INDIAN DRUGSPub Date : 2023-07-03DOI: 10.53879/id.60.06.13038
Manojkumar K. Munde, Nilesh S. Kulkarni, A. K. Sen, Dhanya B. Sen
{"title":"A NOVEL VALIDATED STABILITY INDICATING METHOD FOR QUANTIFICATION OF EMPAGLIFLOZIN IN BULK AND MARKETED FORMULATION BY HPTLC APPLYING EXPERIMENTAL DESIGN APPROACH","authors":"Manojkumar K. Munde, Nilesh S. Kulkarni, A. K. Sen, Dhanya B. Sen","doi":"10.53879/id.60.06.13038","DOIUrl":"https://doi.org/10.53879/id.60.06.13038","url":null,"abstract":"For the purpose of analyzing empagliflozin, a stability indicating high performance thin layer chromatographic method was developed. This method was optimized using design of experiment. In order to optimize the process, independent variables such as the proportion of isopropyl alcohol in the mobile phase, the duration of time that the chamber was saturated and the distance of mobile phase travelled were considered. On an aluminum plate that had previously been coated with silica gel, development was carried out with the assistance of twin trough glass chambers in ascending lines. The findings from these studies led to the selection of a mobile phase that had a composition of ammonium acetate (2 %), triethylamine and isopropyl alcohol in the ratio of 4:1:5 (V/V/V), and this mobile phase was utilized in the process of method development using central composite design approach. The saturation time was established at 10 minutes, and the ultraviolet detection was performed at a wavelength of 237 nm. The value 0.82 was discovered to be the retention factor (Rf ) for empagliflozin. The method was linear, precise and accurate over the entire concentration range examined (100-600 ng band-1), along with correlation coefficient value of 0.992. The proposed method is quick and selective, and a straightforward method of sample preparation and analysis for empagliflozin in its bulk and commercially available dosage forms. The stability of the drug was tested under a variety of different stress conditions in accordance with ICH guidelines, and the results obtained from the force degradations indicate that the developed method is appropriate for stability studies.","PeriodicalId":13409,"journal":{"name":"INDIAN DRUGS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48002190","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
INDIAN DRUGSPub Date : 2023-07-03DOI: 10.53879/id.60.06.12583
Anamika Singh, Tamanna Narsinghan
{"title":"BIOANALYTICAL METHOD VALIDATION: A COMPREHENSIVE ASSESSMENT OF VARIOUS REGULATORY GUIDELINES","authors":"Anamika Singh, Tamanna Narsinghan","doi":"10.53879/id.60.06.12583","DOIUrl":"https://doi.org/10.53879/id.60.06.12583","url":null,"abstract":"Bioanalytical methods are used to analyse an analyte in a biological matrix. Bioanalytical method validation is the process of determining the suitability of the given bioanalytical methodology for providing the required analytical data. Validation of the bioanalytical methods demonstrates and ensures that the methods used for the quantification of analyte in biological fluids are reliable, reproducible and suitable for its intended application. Different regulatory agencies like Food and Drug administration (FDA), The National Health Surveillance Agency or Agência Nacional de Vigilância Sanitária (ANVISA), European Medicines Evaluation Agency (EMA), Ministry of Health, Labor and Welfare (MHLW) and International Conference on Harmonization (ICH), provide guidelines for bioanalytical method validation. The present study provides an insight about the history of bioanalytical method validation including the details of various validation parameters and their description as per the different regulatory guidelines. The study also includes the parameters of ligand based assay methods and their description.","PeriodicalId":13409,"journal":{"name":"INDIAN DRUGS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46670167","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
INDIAN DRUGSPub Date : 2023-07-03DOI: 10.53879/id.60.06.13252
Uditi Handa, Anuj Malik, Kumar Guarve
{"title":"INVESTIGATION OF SUPERFLUITY POTENTIAL OF BCS-II DRUG BY USING SOLVENT SHIFT METHOD","authors":"Uditi Handa, Anuj Malik, Kumar Guarve","doi":"10.53879/id.60.06.13252","DOIUrl":"https://doi.org/10.53879/id.60.06.13252","url":null,"abstract":"This research work’s motive was to investigate the superfluity potential of the BCS-II drug (Dextromethorphan HBr) by solvent shift method to evaluate the impact of polymer gain factor on superfluity potential for the enhancement of bioavailability of orally prolonged release. To maintain the superfluity potential, different drug-release retarding polymers were used (HPMC 15cps, xanthan gum, sodium CMC) in a bio-relevant medium. The outcomes of this, reveal that all polymers remarkably enhanced the solubility of dextromethorphan HBr 1.07-2.49 fold when compared to those without polymer. HPMC and xanthan gum both at 0.1 % w/V showed excellent precipitation inhibitor's role at about 10.2-22.1 factor in SIFsp and 6.04-6.75 factor in PBS (pH 7.4). Elucidation of these results, show that HPMC (15cps) works on the parachute concept and Xanthan Gum on the glider concept. Hence, the superfluity potential is maintained by the selection of excellent polymers in non-formulated drugs to develop the superfluity formulation.","PeriodicalId":13409,"journal":{"name":"INDIAN DRUGS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41858645","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
INDIAN DRUGSPub Date : 2023-07-03DOI: 10.53879/id.60.06.13169
Mrinalini C. Damle, Mayuri H. Suryawanshi
{"title":"OXIDATIVE DEGRADATION OF TAVABOROLE: DETERMINATION BY DERIVATIVE UV SPECTROPHOTOMETRY","authors":"Mrinalini C. Damle, Mayuri H. Suryawanshi","doi":"10.53879/id.60.06.13169","DOIUrl":"https://doi.org/10.53879/id.60.06.13169","url":null,"abstract":"The aim of the present work was to investigate degradation behavior of tavaborole upon exposure to oxidative conditions using first order derivative UV spectrophotometric method. We have developed simple and fast analytical method that can be used as quality control tool for the determination of tavaborole. The method was based on oxidative studies over a period of time. The order of oxidative degradation reaction was calculated by using the log of recovered concentration obtained from the oxidative degradation study. The reaction was first order kinetics. The method was validated according to ICH guidelines. The linear response was found in the concentration range of 5-25 µg mL-1 at 271 nm. The % relative standard deviation (RSD) for precision studies of intraday and interday was ","PeriodicalId":13409,"journal":{"name":"INDIAN DRUGS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"47003542","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
INDIAN DRUGSPub Date : 2023-07-03DOI: 10.53879/id.60.06.13069
Azima G. Munshi, M. Goyani, Meghraj V. Suryawanshi
{"title":"FORMULATION AND DEVELOPMENT OF LONG-ACTING THERMOSENSITIVE AND MUCOADHESIVE VAGINAL GEL OF METRONIDAZOLE","authors":"Azima G. Munshi, M. Goyani, Meghraj V. Suryawanshi","doi":"10.53879/id.60.06.13069","DOIUrl":"https://doi.org/10.53879/id.60.06.13069","url":null,"abstract":"The development of an in situ metronidazole gel that is mucoadhesive and thermo sensitive was the aim of this study in the fight against bacterial vaginosis. Numerous evaluation criteria have been carried out, including mucoadhesive force, pH, viscosity, syringe capability, medication content, gelation temperature, and gelation time. All of the solutions were found to have pH values between 6-7. The viscosity was correlated with the mucoadhesive force. The drug release parameter indicates that in situ gels containing Carbopol 934 provide superior drug release compared to other polymers. Additionally, Carbopol 934 has 118 g more mucoadhesive strength than HEC and HPMC. Compared to non-ionic polymers like HPMC and HEC, Carbopol 934 effectively slows down drug release since it is a cationic polymer. After a 30-day stability test, the gel’s properties barely changed. It follows that the developed formulation of metronidazole in situ gels is more reliable and efficient than earlier vaginal gels.","PeriodicalId":13409,"journal":{"name":"INDIAN DRUGS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"42509428","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
INDIAN DRUGSPub Date : 2023-07-03DOI: 10.53879/id.60.06.13657
N. Sanap, T. Khan
{"title":"PHYTOCHEMICAL SCREENING, ANTIBACTERIAL, ANTIOXIDANT AND ANTIINFLAMMATORY ACTIVITY OF ACMELLA OLERACEA FLOWERS","authors":"N. Sanap, T. Khan","doi":"10.53879/id.60.06.13657","DOIUrl":"https://doi.org/10.53879/id.60.06.13657","url":null,"abstract":"Acmella oleracea flowers are traditionally used to treat mouth ulcers in the rural areas of Nashik, Maharashtra, India. This research project is an effort to understand the scientific basis for the utility of A. oleracea flowers and validate it for potential antimicrobial, anti-inflammatory and antioxidant activity, some of the main causes of mouth ulcers. The aim of this project was to study the phytochemistry of the ethanol extract of A. oleracea flowers and evaluate antibacterial anti-inflammatory and antioxidant potential. The phytochemical screening ethanol extract indicates the presence of phenolics, flavonoids, glycosides, alkaloids and carbohydrates. The total phenolic and flavonoid content in the ethanol extract determined by Folin-Ciocalteu reagent and aluminum chloride method were found to be 29.992 mg GAE g-1 and 93.2 mg QE g-1, respectively. The antibacterial activity of the ethanol extract was evaluated against Escherichia coli, Pseudomonas aeruginosa, Bacillus subtilis and Staphylococcus aureus, using streptomycin as the reference standard. The best activity was observed against P. aeruginosa. The antioxidant activity of the was determined by 2,2-diphenyl-1-picrylhydrazyl, hydrogen peroxide, nitric oxide scavenging and ferric reducing antioxidant power assays. The IC50 in the DPPH, hydrogen peroxide and nitric oxide scavenging assays were found to be 89.589 µg mL-1, 89.178 µg mL-1 and 50.86 µg mL-1 respectively. The anti-inflammatory activity was evaluated by in vitro albumin denaturation assay using naproxen as the reference standard. The ethanol extract demonstrated significant antibacterial, antiinflammatory and antioxidant activity, these combined effects could be responsible for its effectiveness in mouth ulcers and potentially justify the traditional use of A. oleracea flowers in mouth ulcers.","PeriodicalId":13409,"journal":{"name":"INDIAN DRUGS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"46173331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
INDIAN DRUGSPub Date : 2023-07-03DOI: 10.53879/id.60.06.p0005
{"title":"OPPORTUNITIES FOR PHARMA INDUSTRY’S RESEARCH COLLABORATIONS WITH CSIR-CDRI","authors":"","doi":"10.53879/id.60.06.p0005","DOIUrl":"https://doi.org/10.53879/id.60.06.p0005","url":null,"abstract":"Dear Reader, Industry can look forward to work with CSIR-CDRI in this new era of dynamic leadership of CSIR, with Dr. (Mrs) N. Kalaiselvi, the new Director General of CSIR and Secretary, DSIR and Dr. (Mrs) Radha Rangarajan, Director, CDRI, Lucknow, who has recently taken charge of this pioneer pharmaceutical research laboratory in India which has a very distinguished track record in drug discovery research from early days, especially from the times of Dr. Nitya Anand, Director of CSIR-CDRI from 1974 to 1984","PeriodicalId":13409,"journal":{"name":"INDIAN DRUGS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49498437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
INDIAN DRUGSPub Date : 2023-07-03DOI: 10.53879/id.60.06.13865
H. Bajaj, M. Yadav, Seema B. Chauhan, Anjali Sharma, Navin C. Pant, Vinod Singh, Mamta F. Singh
{"title":"ACECLOFENAC LOADED FILM FORMING GELS: IN VIVO STUDY","authors":"H. Bajaj, M. Yadav, Seema B. Chauhan, Anjali Sharma, Navin C. Pant, Vinod Singh, Mamta F. Singh","doi":"10.53879/id.60.06.13865","DOIUrl":"https://doi.org/10.53879/id.60.06.13865","url":null,"abstract":"For arthritis, there is need of development of a drug delivery system which permits less frequent dosing by maintaining a close contact with the skin for prolonged time period, thereby improving the patient compliance, especially among elderly. Till date, film forming gels of aceclofenac for arthritis are not available in the market. It is a novel approach which can be used as an alternative to conventional topical and transdermal formulations to treat arthritis. Therefore, HPMC and Eudragit RL 100 based film forming gels of aceclofenac were prepared. On the basis of in vitro potential, the formulation was further selected and evaluated for their acute skin irritation studies and in vivo anti-arthritic activity using primary skin irritation (draize) test and Freund’s Complete Adjuvant (FCA) induced arthritis method. The tested formulations were devoid of any irritation potential and no edema formation was observed in any cases Irritation score (primary skin irritation index) for all the formulations was found to be zero, which indicates its safety and acceptability for transdermal administration. The in vivo study revealed that there was significant reduction in inflamed paw volume compared to the marketed formulation. The developed film forming gels could be a potential drug delivery platform for the management of arthritis.","PeriodicalId":13409,"journal":{"name":"INDIAN DRUGS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49435851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
INDIAN DRUGSPub Date : 2023-07-03DOI: 10.53879/id.60.06.13200
Celina Nazareth, S. Pereira, R. Batheja
{"title":"A SENSITIVE, ECONOMICAL BIOANALYTICAL LC-MS/MS METHOD FOR SIMULTANEOUS ANALYSIS OF IRBESARTAN AND HYDROCHLOROTHIAZIDE","authors":"Celina Nazareth, S. Pereira, R. Batheja","doi":"10.53879/id.60.06.13200","DOIUrl":"https://doi.org/10.53879/id.60.06.13200","url":null,"abstract":"A novel bioanalytical LC-MS/MS method for irbesartan and hydrochlorothiazide has been developed using deuterated internal standards. Sample pretreatment was carried out using Strata-X Cartridge 33µm. Chromatographic separation was achieved on Chromolith® High Resolution Column, 100X4.6mm, 5µ using a mobile phase of acetonitrile (80 %) and 2mM ammonium acetate (20 %) basified with ammonia solution. A flow rate of 1 mL min-1 was employed with split ratio of approximately 50% outside, with column temperature being 40˚C ±2˚C. The retention time for irbesartan and irbesartanD4 deuterated internal standard was 1.52 min (±0.50min) and for hydrochlorothiazide and hydrochlorothiazide15N213CD2 deuterated internal standard it was 1.43 min (±0.50 min). The developed LC/MS-MS method was validated as per EMA guidelines. The linearity range established for the drugs in human plasma was 50.197 ng mL-1 to 6038.206 ng mL-1 for irbesartan and 1.021 ng mL-1 to 408.480 ng mL-1 for hydrochlorothiazide. The short run time ensured use of less mobile phase and increased sample throughput, making analysis rapid and economical.","PeriodicalId":13409,"journal":{"name":"INDIAN DRUGS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"44712313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
INDIAN DRUGSPub Date : 2023-05-28DOI: 10.53879/id.60.05.12481
Prasanta K. Mohapatra, Sunit K. Sahoo
{"title":"EFFECT OF PREPARATION TEMPERATURE ON ETHYLCELLULOSE MICROSPHERE PROPERTIES PREPARED BY OIL-IN-OIL EMULSION SOLVENT EVAPORATION PROCESS","authors":"Prasanta K. Mohapatra, Sunit K. Sahoo","doi":"10.53879/id.60.05.12481","DOIUrl":"https://doi.org/10.53879/id.60.05.12481","url":null,"abstract":"The present study aims to formulate ethylcellulose microspheres using the oil-in-oil emulsion solvent evaporation method and judge the outcome of processing temperature on their features. The effects of the evaporation rate of the solvent on the particle properties and drug release characteristics of the microspheres were studied. Here, microspheres were prepared at different processing temperatues, viz., 10 0 C, 25 0 C, and 40 0 C, and their impact on the various characteristics of microspheres like surface topography, micrometrics, yield percent, encapsulation efficiency, in vitro dissolution, Fourier-transform infrared spectroscopy (FTIR) and release kinetics were elaborately studied. The FTIR study revealed that processing temperature did not affect drug-polymer compatibility. The study observed that the processing temperature had a great influence on the various characteristics of the prepared microsphere. It was observed from sieve analysis that the mean particle size of the microsphere increased with an increase in processing temperature, and the SEM study also corroborated the same result. SEM photographs showed processing at a higher temperature resulted in particles with a smooth surface, in contrast to a lower processing temperature that forms a bumpy surface. Furthermore, a higher temperature favoured formulation with a higher entrapment efficiency (94.42 ± 0.9 %) as compared to a lower temperature (85.2 ± 0.72 %). For a noteworthy timeframe, indinavir sulfate frames a solid solution in the ethylcellulose matrix and proceeds with the amorphous state. The results of an in vitro drug dissolution study showed that microspheres formulated at a higher temperature had a more sustaining effect as compared to those formulated at a lower temperature, which may have resulted due to their higher mean particle size. Using the Korsemeyer Peppas power law, it was found that the way drugs are released is controlled by diffusion.","PeriodicalId":13409,"journal":{"name":"INDIAN DRUGS","volume":" ","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49398176","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}