地西泮片有关物质的考察

Detection related substance of diazepam tablets

目的:对地西泮片有关物质进行考察,并由此提出对固体口服制剂的有关物质控制的一些看法。方法:采用HPLC法,VP-ODS柱(4.6mm×250mm,5μm),4种流动相系统,检测波长为254nm。结果:11批样品的有关物质总量均小于0.3%,未超过中国药典2005年版对地西泮原料药的有关物质控制要求。结论:通过控制原料药中有关物质的含量以及对生产过程的GMP控制,可以不再对地西泮片剂进行有关物质检测。

Objectives：To detect the related substances of diazepam tablets,and then put forward our opinion on the quality control of oral solid preparation.Methods：Using HPLC method.VP-ODS column （4.6 mm×250 mm,5 μm） and 4 kinds of mobile phase were used.The detection wavelength was 254 nm.Results：The total amounts of the relative substances of each samples were all less than 0.3%,which were less than the limit under diazepam＇s related substances in ChP（2005）.Conclusions：There will be no need to detect the relative substances of diazepam tablets after the quality control of diazepam and the GMP control of manufacturing process.