Quality Test of Commercial Spironolactone Tablets

Abstract

The quality of 5 kinds of commercial spironolactone tablets was evaluated by several tests, such as dissolution, weight variation, content, content uniformity, disintegration and hardness. 2 kinds of apparatus were used in dissolution test: one described in U. S. P. XIX (rotating basket method) and the other in U. S. P. XX (paddle method). 50% dissolution time (T50) differed amo ng samples tested, where the times by rotating basket method were from 3.9 to 120 min or longer and those by paddle method were from 3.6 to 28.2 min., The difference of the apparatus on the dissolution test has an influence on the dissolution rate and T50, whereas T50 of the high dissolution rate samples was nearly equal by either method, but of the low rate samples it was smaller by paddle method than by rotating basket method. Weight variation was 0.6-2.0%, while the disintegration time was less than 7.9 min. Those tests met the requirements in J. P. IX. The content was 98-101% which was within the U. S. P. limits (95-105%), while the content uniformity also satisfied the U. S. P. limits. The hardness was 2.1-7.7kg/cm2.