SIMULTANEOUS DETERMINATION OF EPROSARTAN, HYDROCHLOROTHIAZIDE, AND THEIR RELATED COMPOUNDS IN PHARMACEUTICAL DOSAGE FORMS BY UPLC

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.

Keywords:

• degradant impurities
• eprosartan
• hydrochlorothiazide
• method validation
• stability indicating
• UPLC

ACKNOWLEDGMENTS

The author would like to thank the management of Dr. Reddy's laboratories for providing the facility to perform this research work.

Notes

^a Based on signal to noise (S/N) ratio.

^b Determined on ten levels.

^c Determined on duplicate injections.

^d Average of six determinations.

^e Determined on six values.

^f Hydrochlorothiazide.

^gEprosartan.

^a Determined at six levels (LOQ, 50%, 75%, 100%, 125%, and 150%) with triplicate determination at each level.

^b Determined at five levels (50%, 75%, 100%, 125%, and 150%) with triplicate determination at each level.

^a Numbers in parentheses represent percentage area against respective standard.