地西泮片有关物质的考察
Detection related substance of diazepam tablets
分类号：
出版年·卷·期（页码）：2010,30 (8):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
-----摘要：-------------------------------------------------------------------------------------------
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(4.6 mm×250 mm,5 μm),4种流动相系统,检测波长为254 nm。 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。
-----英文摘要：---------------------------------------------------------------------------------------
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 diazepams 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.
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