Analytical Method Development and Validation by RP-HPLC for Simultaneous Estimation of Esomeprazole and Levosulpiride in Combined Capsule Dosage Form

V. Amaravathi*, Ramesh Dhani, V. Haribaskar, M. Gobinath, M. Shirisha
Department of Pharmaceutical Analysis, Ratnam Institute of Pharmacy, Pidathapolur, Muthukur, SPSR Nellore, A.P, India

A B S T R A C T
A simple, Accurate, precise method was developed for the simultaneous estimation of the esomeprazole and levosulpiride in Capsule dosage form. Chromatogram was run through ODS (150mm 4.6mm, 5µ). Mobile phase containing Buffer and Acetonitrile in the ratio of 32B:68A was pumped through column at a flow rate of 1ml/min. Buffer used in this method was 0.01N KH₂PO₄ pH 5.4 buffer. Temperature was maintained at 30°C. Optimized wavelength for Esomeprazole and Levosulpiride was 290nm. Retention time of Esomeprazole and Levosulpiride were found to be 2.2min and 4.0min. %RSD of the Esomeprazole and Levosulpiride were found to be 0.97 and 0.50 respectively. %Recover was Obtained as 100.08% and 101.16% for Esomeprazole and Levosulpiride respectively. LOD, LOQ values are obtained from regression equations of Esomeprazole and Levosulpiride were 0.10ppm, 0.34ppm and 1.04ppm, 0.29ppm respectively. Regression equation of Esomeprazole is y = 10568.x + 307.3, and of Levosulpiride is y = 11649.x + 1207.
Keywords: Esomeprazole, Levosulpiride, RP-HPLC