Formulation and Validation of An Analytical Method for the Estimation of Rabeprazole Sodium Delayed-Release Tablets

Abstract

Background Rabeprazole sodium is a proton pump inhibitor used for the treatment of peptic ulcer and gastroesophageal reflux disease by inhibiting the enzyme HKATPase the acidic pump. In addition erosive esophagitis and Zollinger-Ellison syndrome are treated with it.In this study the objective was to develop a pharmaceutically stable and cost-effective and quality-improved formulation and UV spectrophotometry method have been developed to estimate Rabeprazole sodium delayed-release tablets. To achieve these goals various prototype formulation trails will be taken and evaluated.Methods Rabeprazole sodium prolonged release tablets were prepared by direct compression technique used to the different excipients as well as varying concentrations of polymer proportion using HPMC phthalate 55 which is an enteric coating material.Results The results indicated that the final product formulation 12 met all the specifications of the physical properties and invitation release and is comparable to the innovator product.Conclusions In the present study Rabeprazole enteric-coated tablets were prepared using HPMC phthalate 55 enteric polymer. Formulation 12 was found to be the best of all formulations showing drug release that matches the innovator product so all quality control tests were performed for conformation for the formulation. The tablets were tested for acid release during the stability period and the results confirmed that the results were within the limits.