Preparation and Quality Control of Warfarin Sodium Granules / 中国药房

ABSTRACT

OBJECTIVE:To prepare warfarin sodium granules(WSG)and to establish it’s quality control methods .METHO_DSTo prepare WSG with part.aeq.geometric method,to optimize the amounts of all sorts of agents in the formulation in terms of dissolution time and abilityof WSG by orthogonal experiment.To determin the content of WS by UV. RESULTS:The formulation was designed and optimized,the WSG’s size were evenly.The concentration of WS was linear within the range of 5.92～17.86?g/ml with r=0.9 998(n=7),the average recovery rate was 101.26%～101.84%(n=5)with the RSD lower than 1.0%.The solution dissolved by granules is stable within 10 days.CONCLUSIONS:The preparation method is simple and feasible,the content determination methods is accurate,realible and sensitive,suitable for the quality control of WSG.The dissolved solution can be divided in accurate doses.