Development and Validation of a High-Performance Liquid Chromatographic Method for Determination of Eprosartan in Bulk Drug and Tablets

Abstract

Abstract A simple, precise, and accurate isocratic RP-HPLC method was developed and validated for determination of eprosartan in bulk drug and tablets. Isocratic RP-HPLC separation was achieved on a Phenomenex C18 column (250 4.6 mm id, 5 m particle size) using the mobile phase 0.5 formic acidmethanolacetonitrile (80 25 20, v/v/v, pH 2.80) at a flow rate of 1.0 mL/min. The retention time of eprosartan was 7.64 0.05 min. The detection was performed at 232 nm. The method was validated for linearity, precision, accuracy, robustness, solution stability, and specificity. The method was linear in the concentration range of 10400 g/mL with a correlation coefficient of 0.9999. The repeatability for six samples was 0.253 RSD; the intraday and interday precision were 0.210.57 and 0.330.71 RSD, respectively. The accuracy (recovery) was found to be in the range of 99.86100.92. The drug was subjected to the stress conditions hydrolysis, oxidation, photolysis, and heat. Degradation products produced as a result of the stress conditions did not interfere with detection of eprosartan; therefore, the proposed method can be considered stability-indicating.