POST MARKETING QUALITATIVE DISSOLUTION TESTING FOR FIXED DOSE TABLETS WITH NEW DEVELOPED VALIDATED METHOD

Fixed dose tablets are gaining value as they give a Fixed dose combination therapy (FDC) method for direction of contrary or synergistic drugs and decrease many doses. However, two different active ingredients or parts of active pharmaceutical ingredients with diverse liberate individually may be formulated as one unit, containing diverse potency. The maximum study is going towards substantial stability (avoidance of delamination), concurrent dissolution testing of dissimilar active pharmaceutical ingredients in fixed dose tablets has been ignored. In this study, a new developed validated method for concurrent analysis of dissolution study of glibenclamide and metformin from fixed dose tablets. Dissolution medium was chosen on the establishment of solubility, sink conditions for drugs. A variety of investigational conditions (kind of equipment, stir rate and volume of dissolution medium) were optimized, and the new method was validated according to ICH and USP guide lines. Investigation of dissolution samples was assessed by HPLC column: Merck LichroCART 250 x 4 C 18(Cat.1.51378) as the stationery phase. The composition of mobile phase was acetonitrile, phosphate buffer( pH5.3, 50:50, v/v). The flow rate of the mobile phase was 1 ml/min at 400C and the wavelength was set at 230 nm. The most excellent dissolution profiles were achieved with 900 ml dissolution medium of Phosphate buffer pH 7.4 at 37± 20C, stirred at 75 rpm utilizing apparatus -II. Total dissolution completed within 45 minutes. Validation criteria revealed accuracy, precession and robustness of the novel method with no any intrusion through sample analysis. Validated method would be useful in fixed dose tablets containing glibenclamide and metformin hcl at any stage of formulation development, quality control investigation and post marketing inspection studies. Keywords: Fixed dose tablets, glibenclamide, metformin ,dissolution, method validation