{"title":"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","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":"{\"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}","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}
A stability indicating RP-HPLC method development and validation for the estimation of combined tablet formulation of Amlodipine & Candesartan
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.
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