Abstract

A simple, sensitive, precise and reliable gradient HPLC method was developed and validated for simultaneous quantitative determination of losartan potassium and its eleven related impurities and degradation products in a tablet formulation. Among them B, C, D, E, F, I and G were related impurities and J, K, L and M were degradation products. Optimum chromatographic separation was carried out on an ACCHROM ODS-C18 (250 mm×4.6 mm, 5 µm) column using mobile phases consisting of acetonitrile and 0.1% phosphoric acid under a gradient elution program. The UV detection wavelength was performed at 220 nm with a flow rate of 1.0 mL/min. The column temperature was maintained at 35 °C. All standard curves obtained exhibited good linear regression (r > 0.9995) within the tested range. All the average recovery rates were in the range of 97.00-103.00% and RSD was less than 2.00% (n = 3). Limits of detection and quantification were determined in the level of ng/mL. The results demonstrated that the validated method was suitable for the simultaneous quantification of losartan potassium and its eleven related impurities and degradation products in a tablet formulation.

Keywords: HPLC, losartan potassium, related impurities and degradation products, simultaneous quantitative determination.