Development and validation of method for determination of esomeprazole and naproxen from cobination product by hplc

Abstract

A simple selective and rapid reversed phase high performance liquid chromatographic (RPHPLC) method for the analysis Esomeprazole and Naproxen has been developed and validated. The separation was achieved from HPLC Column (Cogent, C18 250mm x 4.6 mm, 5 µm) with a mobile phase consisting (Buffer: Acetonitrile: Methanol = 50:40:10, add 0.1% v/v Triethylamine in above mixture and finally adjust with glacial acetic acid to a pH 7.0) flow rate 1.0 ml/min with UV detection at 303 nm. The method was specific and it was observed that no interference with diluents. Proposed method is accurate with (99.87%-100.08%) recovery for Naproxen and (99.44%-99.87%) recovery for Esomeprazole. The proposed method was accurate, and precise for the quantification of Esomeprazole and Naproxen in the tablet. The proposed method can also be used for routine analysis in quality control. The method was validated for the parameters like selectivity, sensitivity, precision, intermediate precision, accuracy, linearity, recovery & stability . This RP -HPLC method is suitable for determining the concentration of Esomeprazole and Naproxen in tablet and it can applied for routine analysis for determination of the Esomeprazole and Naproxen from dosage form.