Development and Validation of Rp-hplc Method for the Simultaneous Estimation of Pantoprazole and Mosapride in Capsule Dosage Form

An estimation method based on RP-HPLC has been identified for determining the concentrations of pantoprazole sodium and mosapride citrate in combined pharmaceutical formulation. The experiment was performed on Hypersil BDS (4.6mm X 150nm), 5μm column in isocratic mode, with 1 mL/min flow of orthophosphoric acid adjusted, mobile phase consisting of a 40:60 mixture of mixed sodium phosphate buffer (0.007M) and acetonitrile of pH 4. A UV detector was used with the measurement of absorption at 278 nm. The method resulted in retention times of 2.803 minutes and 5.167 minutes for pantoprazole sodium and mosapride citrate respectively. The method was validated according to ICH guidelines for system suitability parameters, linearity, precision, accuracy, specificity, ruggedness, robustness. Recoveries of pantoprazole and mosapride were found to be in the range of 99.77% ± 0.23% and 99.44% ± 0.50%. Linearity was observed in the range of 5-30 μg/mL and 1.9-11.4 μg/mL for pantoprazole and mosapride respectively. The LOD for pantoprazole sodium and were Mosapride citrate determined to be 0.1599 μg/mL and 0.1790μg/mL respectively, while LOQ for these were respectively 0.4894 μg/mL and 0.5480 μg/mL. As, all the parameters of ICH guidelines for validation are satisfied, this method is suitable for the simultaneous estimation of pantoprazole sodium and mosapride citrate in combined pharmaceutical formulations.