Development and Validation of High Performance Liquid Chromatography Method for Levosulpiride and its Intermediate in Synthetic Mixture

A simple, accurate and precise chromatography method was developed for Levosulpiride and 2-methoxy 5- sulfamoylbenzoyl benzoic acid methyl ester in synthetic mixture using RP-HPLC Method. In this chromatography method, both drug show its peak at 232 nm. Both the drugs show linearity in a concentration range of 10-50 μg/ml at their respective λmax. Optimize Mobile Phase was Water : Methanol : Acetonitrile (70 : 15 : 15). The relative standard deviation for accuracy, precision studies were found to be within the acceptance range (<2%). The limit of determination was 0.14μg/ml and 0.19μg/ml for Levosulpiride and 2-methoxy 5- sulfamoylbenzoyl benzoic acid methyl ester, respectively. The limit of quantification was 0.42μg/ml and 0.59μg/ml for Levosulpiride and 2-methoxy 5-sulfamoylbenzoyl benzoic acid methyl ester, respectively. Recovery of Levosulpiride and 2-methoxy 5-sulfamoylbenzoyl benzoic acid methyl ester were found to be 100.16 % and 99.15 % respectively confirming the accuracy of the proposed method. The proposed method is recommended for routine analysis since they are rapid, simple, accurate and also sensitive and specific by no heating and no organic solvent extraction.