In the quality test of 2 brands of film coated tablets containing 20mg of metoprolol tartrate, their dissolution, weight variation, content uniformity, disintegration and hardness were studied. Their weight variation was 0.8 to 1.9%, content 20.1 to 20.4mg, and disintegration time less than 10.8 min, all meeting the JP X requirements. The hardness was 5.7 to 6.3 kg/ cm
2.
In the dissolution test with use of the 1st fluid (Disintegration Test, JP X) by rotatory basket method, 50 and 90% dissolution times (T
50 and T
90) of the 2 brands were almost the same, while the results obtained by the paddle method were not so different from those by rotatory basket method. In addition, the effect of pH on T
50 and T
90 was studied. T
50 and T
90 of 2 brands were influenced slightly by pH of dissolution fluid. No other significant differences were observed between 2 brands.
抄録全体を表示