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Present study deals with the development and validation of a rapid, simple and efficient method for the simultaneous determination as well as stability studies of Esomeprazole and Levosulpiride in bulk and formulations. The method involves reverse phase High Performance Liquid Chromatography (HPLC) using stationery Phase ODS C18 column (250mm x 4.6 mm, 5m), Mobile phase as Phosphate buffer, Acetonitrile and methanol at the ratio of 65:30:5, subjected to isocratic elution, observed the peaks with PDA detector wavelength 254nm, maintaining the mobile phase flow rate at 1ml/minute, keeping the run time fixed for 8 minutes. Column temperature was maintained at 300C, pH of the mobile phase was 3.0; complete separation of both the compounds took place within four minutes. Retention time was found 2.41 minutes and 3.56 minutes for Esomeprazole and Levosulpiride respectively. The developed new method was validated as per ICH guideline taking the parameters like accuracy, precision, linearity, limit of detection, limit of quantification, intermediate precision and robustness. In the linearity test Correlation Coefficient was found to be 0.999 for both the molecules, percentage relative standard deviation results from precision studies were 0.34 and 0.44; mean percentage recoveries in accuracy studies were found to be 100.35% and 100.14% for Esomeprazole and Levosulpiride respectively. Very low concentrations of LOD and LOQ indicate the method was highly sensitive enough. The designed validated method can be used effectively in the laboratory for regular determination of Levosulpiride and Esomeprazole in formulation and bulk form.

Stability Indicating Method Development and Validation for the Simultaneous Determination of Levosulpiride and Esomeprazole in Bulk and Formulation