STABITY INDICATING DISSOLUTION METHOD DEVELOPMENT FOR ESTIMATION OF METHYLDOPA AND HYDROCHLOROTHIAZIDE IN COMBINE DOSAGE FORM

The aim of this work was to develop validate a dissolution test for Methyldopa and Hydrochlorothiazide in combination tablets using spectrophotometric method. The dissolution established conditions were 900 mL of 0.1M HCl pH 1.0 as dissolution medium, using a paddle apparatus at a stirring rate of 50 rpm. The drug release was evaluated by UV spectrophotometric method the areas of solution were recorded at 274-284 nm and266-276 nm for Methyldopa and Hydrochlorothiazide respectively. It can be concluded that the method developed consists in an efficient alternative for assay of dissolution for tablets. The method was validated to meet requirements for a global regulatory filing which includes linearity, precision, accuracy robustness and ruggedness. In addition, filter suitability and drug stability in medium were demonstrated Keywords: In vitro release, Stability, Dissolution study of methyldopa and Hydrochlorothiazide, Spectrophotometry, Area under curve method, Validation.