Development and Validation of High Performance Thin LayerChromatography for Determination of Esomeprazole Magnesium inHuman Plasma

Abstract

A simple, sensitive, rapid and economic high performance thin layer chromatographic method has been developed for determination of Esomeprazole magnesium in human plasma by liquid-liquid extraction. The plasma sample was extracted using chloroform. A concentration range from 200-700 ng/spot of Esomeprazole magnesium was used for calibration curve. The percent recovery of Esomeprazole magnesium was found 101.61 percent. The mobile phase constitute of ethyl acetate: methanol: ammonia (32%) (9:1: 0.5 v/v). Densiometric analysis was carried out at wavelength 301 nm. The Rf value for Esomeprazole magnesium was found 0.54 ± 0.05. The stability of Esomeprazole magnesium in human plasma was confirmed during freeze thaw cycles at -30°C, on bench top during 24 h at room temperature and post preparative for 48 h. The proposed method was validated statistically by performing recovery study for determination of Esomeprazole magnesium in human plasma by liquid-liquid extraction.