Development and validation of a HPTLC method for the simultaneous estimation of atorvastatin calcium and ezetimibe
Development and validation of a HPTLC method for the simultaneous estimation of atorvastatin calcium and ezetimibe
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同时测定阿托伐他汀钙和依折麦布的 HPTLC 方法的开发和验证
DOI：
10.4103/0250-474x.31018
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发表时间：
2006
影响因子：
0.5
通讯作者：
K. Modi
中科院分区：
文献类型：
--
作者：
B. Chaudhari;N. Patel;P. Shah;K. Modi
建立了一种简便、准确、准确、快速的高效薄层层析法同时测定阿托伐他汀钙和依折麦布联合制剂中阿托伐他汀钙和依折麦布的含量。所用固定相为预涂硅胶60F254。流动相为氯仿：苯：甲醇：冰醋酸(6.0：3.0：1.0：0.1v/v)；斑点检测在250 nm处进行。对方法的线性、准确度、精密度和专属性进行了验证。阿托伐他汀钙的线性范围为0.8-4.0微克/点，依折麦布的线性范围为0.1-1.0微克/点。阿托伐他汀钙的检出限和定量限分别为170 ng/斑点和570 ng/斑点；依折麦布的检测限和定量下限分别为20 ng/斑点和70 ng/斑点。该方法可用于市售制剂中药物含量的测定。
A simple, precise, accurate and rapid high-performance thin-layer chromatographic method has been developed and validated for the estimation of atorvastatin calcium and ezetimibe simultaneously in combined dosage forms. The stationary phase used was precoated silica gel 60F254. The mobile phase used was a mixture of chloroform: benzene: methanol: acetic acid (6.0:3.0:1.0:0.1 v/v/v/v). The detection of spots was carried out at 250 nm. The method was validated in terms of linearity, accuracy, precision and specificity. The calibration curve was found to be linear between 0.8 and 4.0 µg/spot for atorvastatin calcium and 0.1 and 1.0 µg/spot for ezetimibe. The limit of detection and the limit of quantification for atorvastatin calcium were found to be 170 ng/spot and 570 ng/spot respectively, and for ezetimibe, 20 ng/spot and 70 ng/spot respectively. The proposed method can be successfully used to determine the drug content of marketed formulation.