A stability indicating RP-HPLC method development and validation for the estimation of combined tablet formulation of Amlodipine & Candesartan

Proceedings of 4th International Electronic Conference on Medicinal Chemistry Pub Date : 2018-10-31 DOI:10.3390/ECMC-4-05585

S. D. Patil, Sunil V. Amurutkar, C. Upasani

{"title":"A stability indicating RP-HPLC method development and validation for the estimation of combined tablet formulation of Amlodipine & Candesartan","authors":"S. D. Patil, Sunil V. Amurutkar, C. Upasani","doi":"10.3390/ECMC-4-05585","DOIUrl":null,"url":null,"abstract":"A stability indicating High Performance Liquid Chromatographic (HPLC) method was developed and validated for the estimation of combined tablet formulation of Amlodipine & Candesartan. Chromatographic separation was optimized by Binary Gradient System HPLC on a Grace C18 (250mm x 4.6ID, Particle size: 5 micron) utilizing a mobile phase consisting a methanol: phosphate buffer (pH-3, adjusted with 0.1% OPA) 80:20 % v/v at a flow rate of 0.8ml/min with UV-3000-M at 244nm. The retention time of Amlodipine & Candesartan was 4.2min and 6.3 min respectively.\nGood linearity was obtained over the range of 5 μg/ml to 25 μg/ml & 8 μg/ml to 40 μg/ml for Amlodipine & Candesartan. Correlation coefficient was found to be 0.999 for both derivatives. The % RSD of precision Amlodipine & Candesartan was found to be 0.54 and 0.60 respectively. The % mean recovery was found to 98.93-99.00 % for Amlodipine and 99.75-99.87 %for Candesartan. The results obtained for accuracy, precision, LOD, LOQ and Ruggedness were within the limits. Thus the validated economical method was applied for forced degradation study of Amlodipine & Candesartan tablets.","PeriodicalId":20450,"journal":{"name":"Proceedings of 4th International Electronic Conference on Medicinal Chemistry","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2018-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"1","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Proceedings of 4th International Electronic Conference on Medicinal Chemistry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3390/ECMC-4-05585","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}

引用次数: 1

Abstract

A stability indicating High Performance Liquid Chromatographic (HPLC) method was developed and validated for the estimation of combined tablet formulation of Amlodipine & Candesartan. Chromatographic separation was optimized by Binary Gradient System HPLC on a Grace C18 (250mm x 4.6ID, Particle size: 5 micron) utilizing a mobile phase consisting a methanol: phosphate buffer (pH-3, adjusted with 0.1% OPA) 80:20 % v/v at a flow rate of 0.8ml/min with UV-3000-M at 244nm. The retention time of Amlodipine & Candesartan was 4.2min and 6.3 min respectively. Good linearity was obtained over the range of 5 μg/ml to 25 μg/ml & 8 μg/ml to 40 μg/ml for Amlodipine & Candesartan. Correlation coefficient was found to be 0.999 for both derivatives. The % RSD of precision Amlodipine & Candesartan was found to be 0.54 and 0.60 respectively. The % mean recovery was found to 98.93-99.00 % for Amlodipine and 99.75-99.87 %for Candesartan. The results obtained for accuracy, precision, LOD, LOQ and Ruggedness were within the limits. Thus the validated economical method was applied for forced degradation study of Amlodipine & Candesartan tablets.

查看原文

微信好友朋友圈 QQ好友复制链接

本刊更多论文

氨氯地平坎地沙坦联合片剂处方稳定性指示反相高效液相色谱法的建立与验证

建立了一种具有稳定性的高效液相色谱法(HPLC)评价氨氯地平坎地沙坦联用片剂的处方。采用二元梯度系统高效液相色谱法，在Grace C18 (250mm × 4.6ID，粒径:5微米)上优化色谱分离，流动相为甲醇:磷酸盐缓冲液(pH-3, 0.1% OPA调节)80:20% v/v，流速为0.8ml/min，紫外-3000- m波长为244nm。氨氯地平和坎地沙坦的保留时间分别为4.2min和6.3 min。氨氯地平和坎地沙坦在5 ~ 25 μg/ml和8 ~ 40 μg/ml范围内线性良好。两个导数的相关系数均为0.999。氨氯地平和坎地沙坦精密度的% RSD分别为0.54和0.60。氨氯地平的平均回收率为98.93 ~ 99.00%，坎地沙坦的平均回收率为99.75 ~ 99.87%。所得结果的准确度、精密度、LOD、LOQ和坚固性均在限定范围内。采用经验证的经济方法对氨氯地平坎地沙坦片进行强制降解研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文去求助

来源期刊

Proceedings of 4th International Electronic Conference on Medicinal Chemistry

自引率

0.00%

发文量