摘要
目的:探讨维生素D_(2)有关物质的各种检测方法。方法:采用高效液相色谱法,分别考察《中国药典》项下的正相色谱方法和《欧洲药典》项下的反相色谱方法,对维生素D_(2)有关物质检测结果的影响。结果:采用反相色谱系统,能够更多检出维生素D_(2)中的有关物质。结论:反相色谱方法更适用于维生素D_(2)的有关物质检测。
Objective:To study various methods for the determination of related substances of vitamin D_(2).Methods:The high-performance liquid chromatography was used to investigate the influence of the methods of normal-phase chromatography and reversed-phase chromatography in the Chinese pharmacopoeia on the detection results of related substances of vitamin D_(2).The results were compared with those of the methods of reverse-phase chromatography in the Chinese pharmacopoeia and the European pharmacopoeia.Results:More related substances in vitamin D_(2)can be detected by reversed phase chromatography system.Conclusion:The reversed-phase chromatography method is more suitable for the determination of related substances of vitamin D_(2).
作者
李婕
袁松
黄海伟
陈华
LI Jie;YUAN Song;HUANG Haiwei;CHEN Hua(NMPA Key Labboratory for Quality Research and Evaluation of Chemical Drugs,National Institute for Food and Drug Control,Beijing 102629,China)
出处
《中国药品标准》
CAS
2023年第1期72-76,共5页
Drug Standards of China
关键词
维生素D_(2)
有关物质
正相色谱
反相色谱
vitamin D_(2)
related substances
normal phase chromatography
reversed phase chromatography