不同过滤方法对富马酸酮替芬片含量和含量均匀度测定的影响

Effects of different filtration methods in determination of content and content uniformity of Ketotifen Fumarate Tablets

目的探讨不同的过滤方法对富马酸酮替芬片含量及其均匀度测定的影响。方法分别用滤纸(LPM-1:弃去初滤液40mL;LPM-2:弃去初滤液50mL)、混合纤维素酯膜微孔滤膜(CFMF)过滤,按《中国药典》二部依次测定富马酸酮替芬含量及含量均匀度,并对数据进行比较。结果不同过滤方法测定4批样品,含量和含量均匀度均符合中国药典的规定,但测定结果存在显著性差异。结论两种过滤方法操作方便均可选用。

OBJECTIVE To discuss the different filtration methods for determination of content and content uni- formity of Ketotifen Fumarate Tablets. METHODS Ketotifen Fumarate tablets content as well as content uniformity were detected according to the method cited from Chinese Pharmacopeia （Issue 2） using filtration methods of LPM （ LPM-1 ： primary filtrate 40mL, LPM-2 ： primary filtrate 50mL） and CFMF and compared the results. RESULTS The data of content and content uniformity indicated that there was significant difference （ P 〈 0. 05） between the two kinds of filtration methods though the results were quite up to the regulation of Chinese Pharmaco- peia. CONCLUSION The two kinds of filtration methods are easy to operate and either of them e.n ha ,,.,~,t