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 mthyldopa 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 area of solution were recorded at 274-284 nm and266-276 nm for MD and HCTZ 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 mthyldopa and Hydrochlorothiazide, Spectrophotometry, Area under curve method, Validation