Simultaneous Estimation of Esomeprazole and Levosulpiride in Bulk and in Capsule Formulation by Rp-hplc

The present work deals with development and validation for simultaneous determination of Esomeprazole and Levosulpiride drugs in pharmaceutical formulations. A rapid, precise and specific reverse phase high performance liquid chromatography (RP-HPLC) method was developed for Esomeprazole and Levosulpiride. Chromatographic separations was achieved on a C-18 (5μm, 250×4.6 mm) HPLC column within a runtime of 10 min. Isocratic mobile phase contain methanol: buffer (pH 3) (65:35% v/v) and flow rate was maintained at 1.0 mL/min. Eluate was monitored at 260 nm. Levosulpiride was eluated at 2.7 min and Esomeprazole at 5.7 min. Linearity was studied in the concentratiosn range of 5 to 30 μg mL-1 and 10 to 60 μg/ mL for esomeprazole and levosulpiride respectively, with a correlation coefficient of 0.9995 and 0.9993 respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness.