Abstract
A stability indicating UPLC method was developed and validated for simultaneous determination of eprosartan, hydrochlorothiazide, and their impurities in tablets. The chromatographic separation was performed on Acquity® HSS C18 column (1.7 µm, 2.1 mm × 150 mm) by adopting gradient elution using acetonitrile and disodium hydrogen phosphate buffer (0.01 M ; pH 5.5 adjusted with phosphoric acid) at flow rate of 0.3 mL/min. UV detection was performed at 274 nm. Total run time was 20 min for performing the analysis in which two main compounds and ten other known, unknown impurities were separated. The method was suitably validated with respect to linearity, limit of detection, limit of quantification, accuracy, precision, and selectivity. The calibration curves obtained for the ten impurities were linear over the range 0.017 to 3.79 µg/mL. The relative standard deviations of intra- and inter-day experiments were less than 1.0%. The detection limits ranged between 0.005 to 0.15 µg/mL depending on the impurity.
Published Version
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