采用PDA检测器同时测定原料药及片剂剂型中阿托伐他汀和依折麦布的新型验证反相高效液相色谱分析方法
New Validated RP-HPLC Analytical Method for Simultaneous Estimation of Atorvastatin and Ezetimibe in Bulk Samples as Well in Tablet Dosage Forms by Using PDA Detector.
作者信息
Kumar S Ashutosh, Debnath Manidipa, Seshagiri Rao J V L N
机构信息
Department of Pharmaceutical Analysis & Quality Assurance, A.K.R.G College of Pharmacy, Nallajerla, West Godavari, 534112, A.P, India.
出版信息
Curr Drug Discov Technol. 2014;11(4):259-70. doi: 10.2174/1570163812666150101154857.
This paper describes a new RP-HPLC method for simultaneous quantification of these compounds in the bulk sample drug as well as in tablet dosage forms. The chromatographic separation was performed on an XTerra C8 (4.6 x 250 mm; 5 µm), with phosphate buffer [pH 3.5] and acetonitrile in the ratio of 40:60 (v/v) as mobile phase. The detection was carried out at 240 nm. The accuracy was found to be 99.59% and 98.98% for atorvastatin and ezetimibe respectively. The linearity was 5-25 µg/ml for both the drugs. The intra-day RSD was 0.57% and inter-day RSD was 0.13% for atorvastatin calcium and intra-day RSD was 0.56% and inter-day RSD was 0.09% for ezetimibe. The validation of method was carried out utilizing ICH-guidelines.
本文描述了一种新的反相高效液相色谱法，用于同时定量原料药以及片剂剂型中的这些化合物。色谱分离在XTerra C8（4.6×250 mm；5 µm）柱上进行，以磷酸盐缓冲液[pH 3.5]和乙腈按40:60（v/v）的比例作为流动相。检测波长为240 nm。阿托伐他汀和依折麦布的准确度分别为99.59%和98.98%。两种药物的线性范围均为5 - 25 µg/ml。阿托伐他汀钙的日内相对标准偏差为0.57%，日间相对标准偏差为0.13%；依折麦布的日内相对标准偏差为0.56%，日间相对标准偏差为0.09%。该方法依据国际协调会议（ICH）指南进行了验证。
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