{"title":"反相高效液相色谱法测定原料药和制剂中二甲双胍和恩格列净的稳定性指示方法的建立与验证","authors":"M. Rohini, M. Ajitha","doi":"10.54037/wjps.2022.100108","DOIUrl":null,"url":null,"abstract":"A simple, Accurate, precise method was developed for the simultaneous estimation of the Metformin and Empagliflozin in Tablet dosage form. Chromatogram was run through Std Symmetry 150 x 4.6 mm, 5. Mobile phase containing 0.1% OPA Buffer: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1ml/min. Buffer used in this method was 0.1% OPA buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 230 nm. Retention time of Metformin and Empagliflozin were found to be 2.276min and 2.890min. %RSD of the Metformin and Empagliflozin were and found to be 0.9 and 0.6 respectively. %Recovery was obtained as 100.87% and 100.43% for Metformin and Empagliflozin respectively. LOD, LOQ values obtained from regression equations of Metformin and Empagliflozin were 0.23, 0.75 and 0.01, 0.03 respectively. Regression equation of Metformin is y =27483x + 7407, and y =26728x + 133.3 of Empagliflozin. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.","PeriodicalId":23975,"journal":{"name":"World journal of Pharmacy and pharmaceutical sciences","volume":"92 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Stability Indicating Method Development and Validation for Determination of Metforminand Empagliflozin in Bulk and Pharmaceutical Dosage Form by RP-HPLC\",\"authors\":\"M. Rohini, M. Ajitha\",\"doi\":\"10.54037/wjps.2022.100108\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"A simple, Accurate, precise method was developed for the simultaneous estimation of the Metformin and Empagliflozin in Tablet dosage form. Chromatogram was run through Std Symmetry 150 x 4.6 mm, 5. Mobile phase containing 0.1% OPA Buffer: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1ml/min. Buffer used in this method was 0.1% OPA buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 230 nm. Retention time of Metformin and Empagliflozin were found to be 2.276min and 2.890min. %RSD of the Metformin and Empagliflozin were and found to be 0.9 and 0.6 respectively. %Recovery was obtained as 100.87% and 100.43% for Metformin and Empagliflozin respectively. LOD, LOQ values obtained from regression equations of Metformin and Empagliflozin were 0.23, 0.75 and 0.01, 0.03 respectively. Regression equation of Metformin is y =27483x + 7407, and y =26728x + 133.3 of Empagliflozin. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.\",\"PeriodicalId\":23975,\"journal\":{\"name\":\"World journal of Pharmacy and pharmaceutical sciences\",\"volume\":\"92 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"World journal of Pharmacy and pharmaceutical sciences\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.54037/wjps.2022.100108\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"World journal of Pharmacy and pharmaceutical sciences","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.54037/wjps.2022.100108","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
摘要
建立了同时测定片剂中二甲双胍和依帕列净含量的简便、准确、精确的方法。通过Std Symmetry 150 x 4.6 mm, 5运行色谱图。流动相含0.1% OPA缓冲液:乙腈按60:40的比例以1ml/min的流速泵入柱中。本方法所用缓冲液为0.1% OPA缓冲液。温度保持在30°C。优选波长为230 nm。二甲双胍和依帕列净的滞留时间分别为2.276min和2.890min。二甲双胍和依帕列净的RSD分别为0.9和0.6。二甲双胍和依帕列净的回收率分别为100.87%和100.43%。二甲双胍和依帕列净的LOD、LOQ分别为0.23、0.75和0.01、0.03。二甲双胍的回归方程为y =27483x + 7407,恩格列净的回归方程为y =26728x + 133.3。该方法减少了滞留时间,缩短了运行时间,简便、经济,可用于工业中常规的质量控制试验。
Stability Indicating Method Development and Validation for Determination of Metforminand Empagliflozin in Bulk and Pharmaceutical Dosage Form by RP-HPLC
A simple, Accurate, precise method was developed for the simultaneous estimation of the Metformin and Empagliflozin in Tablet dosage form. Chromatogram was run through Std Symmetry 150 x 4.6 mm, 5. Mobile phase containing 0.1% OPA Buffer: Acetonitrile taken in the ratio 60:40 was pumped through column at a flow rate of 1ml/min. Buffer used in this method was 0.1% OPA buffer. Temperature was maintained at 30°C. Optimized wavelength selected was 230 nm. Retention time of Metformin and Empagliflozin were found to be 2.276min and 2.890min. %RSD of the Metformin and Empagliflozin were and found to be 0.9 and 0.6 respectively. %Recovery was obtained as 100.87% and 100.43% for Metformin and Empagliflozin respectively. LOD, LOQ values obtained from regression equations of Metformin and Empagliflozin were 0.23, 0.75 and 0.01, 0.03 respectively. Regression equation of Metformin is y =27483x + 7407, and y =26728x + 133.3 of Empagliflozin. Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.