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用于同时测定原料药及制剂中厄贝沙坦甲磺酸盐和氢氯噻嗪的紫外分光光度法的建立与验证

Development and Validation of a UV Spectrophotometric Method for the Simultaneous Estimation of Eprosartan Mesylate and Hydrochlorothiazide in Bulk and Formulations.

作者信息

Anandakumar K, Santhi D Vijaya, Jothieswari D, Subathrai R, Vetrichelvan T

机构信息

Department of Pharmaceutical Analysis, Adhiparasakthi College of Pharmacy, Melmaruvathur-603 319, India.

出版信息

Indian J Pharm Sci. 2011 Sep;73(5):569-72. doi: 10.4103/0250-474X.99017.

Abstract

A simple, efficient, precise and accurate absorbance ratio method have been developed for the estimation of eprosartan mesylate and hydrochlorothiazide in pure and in fixed dose combination. In this method, UV spectra of eprosartan mesylate and hydrochlorothiazide were overlayed which involves the formation of Q-absorbance equation at 249.1 nm (isobestic point) and 274.5 nm, the max of hydrochlorothiazide. Both the drugs obeyed Beers law in the concentration range of 6-36 μg/ml and 1-10 μg/ml for eprosartan mesylate and hydrochlorothiazide, respectively. The accuracy of the method was determined by recovery studies and was found to be in the range of 102.29-103.10% and 99.52-101.60% for eprosartan mesylate and hydrochlorothiazide, respectively. The method was validated as per ICH guidelines and statistically. The method showed good reproducibility and recovery with % RSD less than 2. The method was found to be simple, economic, accurate and reproducible and can be used for routine analysis of eprosartan mesylate and hydrochlorothiazide in pure and in fixed dose combinations.

摘要

已开发出一种简单、高效、精确且准确的吸光度比值法,用于测定纯品及固定剂量复方中的甲磺酸依普罗沙坦和氢氯噻嗪。在该方法中,将甲磺酸依普罗沙坦和氢氯噻嗪的紫外光谱进行叠加,这涉及在249.1 nm(等吸收点)和274.5 nm(氢氯噻嗪的最大吸收波长)处形成Q吸光度方程。两种药物在甲磺酸依普罗沙坦浓度范围为6 - 36 μg/ml、氢氯噻嗪浓度范围为1 - 10 μg/ml时均符合比尔定律。通过回收率研究确定了该方法的准确度,结果发现甲磺酸依普罗沙坦和氢氯噻嗪的回收率分别在102.29 - 103.10%和99.52 - 101.60%范围内。该方法按照ICH指南进行了验证并进行了统计学分析。该方法具有良好的重现性和回收率,相对标准偏差(%RSD)小于2。该方法被发现简单、经济、准确且可重现,可用于纯品及固定剂量复方中甲磺酸依普罗沙坦和氢氯噻嗪的常规分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9e3f/3425070/bc4b1e07333b/IJPhS-73-569-g001.jpg

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