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用于同时测定片剂剂型中阿托伐他汀钙和非诺贝特的反相高效液相色谱法的开发与验证

Development and Validation of RP-HPLC Method for Simultaneous Estimation of Atorvastatin Calcium and Fenofibrate in Tablet Dosage Forms.

作者信息

Jain N, Raghuwanshi R, Jain Deeti

机构信息

School of Pharmaceutical Sciences, Rajiv Gandhi Proudhyogiki Vishwavidhyalaya, Bhopal-462 036, India.

出版信息

Indian J Pharm Sci. 2008 Mar-Apr;70(2):263-5. doi: 10.4103/0250-474X.41473.

DOI:10.4103/0250-474X.41473

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2792487/

Abstract

A reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of atorvastatin calcium and fenofibrate in tablet formulation. The separation was achieved by Luna C18 column and methanol:acetate buffer pH 3.7 (82:18 v/v) as mobile phase, at a flow rate of 1.5 ml/min. Detection was carried out at 248 nm. Retention time of atorvastatin calcium and fenofibrate was found to be 3.02+0.1 and 9.05+0.2 min, respectively. The method has been validated for linearity, accuracy and precision. Linearity for atorvastatin calcium and Fenofibrate were in the range of 1-5 mug/ml and 16-80 mug/ml, respectively. The mean recoveries obtained for Atorvastatin calcium and fenofibrate were 101.76% and 100.06%, respectively. Developed method was found to be accurate, precise, selective and rapid for simultaneous estimation of atorvastatin calcium and fenofibrate in tablets.

摘要

建立了一种反相高效液相色谱法，用于同时测定片剂制剂中的阿托伐他汀钙和非诺贝特。采用Luna C18柱，以甲醇：pH 3.7的醋酸盐缓冲液（82:18 v/v）为流动相，流速为1.5 ml/min进行分离。检测波长为248 nm。发现阿托伐他汀钙和非诺贝特的保留时间分别为3.02±0.1分钟和9.05±0.2分钟。该方法已进行线性、准确度和精密度验证。阿托伐他汀钙和非诺贝特的线性范围分别为1-5 μg/ml和16-80 μg/ml。阿托伐他汀钙和非诺贝特的平均回收率分别为101.76%和100.06%。所建立的方法对于片剂中阿托伐他汀钙和非诺贝特的同时测定具有准确、精密、选择性好和快速的特点。