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

开发和验证一种紫外分光光度法同时测定原料药和制剂中甲磺酸依普罗沙坦和氢氯噻嗪的含量

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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.

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