Development and validation of a UV spectrophotometric method for the simultaneous estimation of eprosartan mesylate and hydrochlorothiazide in bulk and formulations

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.

Method Development and Validation of Eprosartan Mesylate and Its Impurities Using Reverse Phase High-Performance Liquid Chromatography

“…The recoveries of EM, EMP RC01 and EMP RC05 were evaluated. The mean percentage recoveries for LOQ, 50%, 80%, 100%, 150% and 200% accuracy were found to be 101.5%±1 5,. 107%±1.6, 104.6%±0.4, 102.8%±0.4, 101.7%±0.3 and 101.3%±0.2 respectively for EM; 103.9%±1.2, 96%±1.4, 96.2%±0.7, 97.5%±0.2, 98.1%±0.3 and 97.8%±0.2 respectively for the EMP RC01; and 98.6%±1.1, 103%±2.9, 99%±2.0, 96.8%±0.8, 96.2%±1.3 and 101.7%±0.6 respectively for the EMP RC05.…”

“…The principal objective for that is to enhance the conditions and parameters, which should be observed in the evolution and establishment. From the literature review, it was found that there are few methods for the estimation of EM, Impurity A and Impurity B. but many methods for individual analysis of the drugs are present [5][6][7][8][9][10][11][12][13][14]. Hence it is aimed to acquire novel methods for the estimation of EM, impurity A and Impurity B using available analytical technique HPLC.…”

“…Hence it is aimed to acquire novel methods for the estimation of EM, impurity A and Impurity B using available analytical technique HPLC. Granting to the literature survey, few analytical methods such as UV-Visible (Vis) spectrophotometry [5][6][7][8], RP-HPLC [9][10][11][12], HPTLC [13] methods were covered for the estimation of EM individually and LC-MS and LCNMR method is for degradation products of EM [14]. The aim of the suggested method is to develop a simple and accurate methods for the determination of EM and its impurities A and B using the RP-HPLC technique in tablets.…”

Quality by design: A systematic and rapid liquid chromatography and mass spectrometry method for eprosartan mesylate and its related impurities using a superficially porous particle column

“…Therefore, as per ICH guideline Q3A (R2), analytical monitoring of impurities in drug substances and formulations is very crucial for quality assurance and safety of the drug . An extensive literature search revealed that a few analytical methods have been reported for the determination of EPR alone and in combination with other drugs in bulk and different formulations by using UV spectrophotometry and LC techniques. A stability‐indicating UHPLC method was reported for simultaneous determination of EPR and hydrochlorothiazide.…”