Abstract

DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF LEVOSULPIRIDE AND ESOMEPRAZOLE IN COMBINED PHARMACEUTICAL FORMULATION

Rachana Patel*, Jagdish Kakadiya, Pinak Patel, Nehal Shah

ABSTRACT

Current research work describes rapid high performance thin layer chromatographic determination of Levosulpiride and Esomeprazole from its combined pharmaceutical formulation. The mention drugs were spotted on silica gel F254 TLC plates under pure nitrogen stream by Linomat TLC spotter. Separation was carried out by using Toluene: Methanol: Ethyl acetate: Ammonia as mobile phase in ratio of 4:3:3:0.2, v/v/v/v. Developed TLC plates were scanned by CAMAG TLC scanner and detection was carried out at 301nm. Rf value of separated drugs was found to be 0.34 ± 0.00288 and 0.66 ± 0.00577 for LEVO and ESO, respectively. The developed method was validated as per ICH guidelines by studying various validation parameters like Accuracy, Precision, Robustness, LOD, LOQ and solvent stability. The developed and validated method was successfully applied for determination of LEVO and ESO from its combined pharmaceutical formulation.

Keywords: Levosulpiride (LEVO), Esomeprazole magnesium trihydrate (ESO), High performance Thin Layer chromatography, Analytical method validation.