盐酸多西环素片有关物质测定方法的讨论  

Discussion on Determination Method of Related Substances in Doxycycline Hyclate Tablets

作　　者：马仕洪[1] 武秀娟[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药品标准》2004年第6期54-57,共4页Drug Standards of China

摘　　要：目的:讨论中国药典盐酸多西环素片有关物质测定方法的合理性。方法:以一批盐酸多西环素片为例,通过改变色谱条件,分别测定盐酸多西环素片中有关物质的含量,比较结果的异同,并分析原因。结果:同一批样品,在中国药典允许的调整范围内改变色谱条件,可以得出截然不同的结论,通过 HPLC-PDA 分析,发现是由于样品中有一未知杂质,按现行中国药典方法未得到分离,而依据现行判定方法造成误判所致。结论:中国药典盐酸多西环素片有关物质测定方法有待完善。Objective:To discuss the determination method of related substances in Doxycycline Hyclate Tablets in Chinese Pharmacopoeia(for short CP).Methods:We assayed the related substances in the same sample by different HPLC conditions, and analysed the results.Results:We tested the same sample by different HPLC conditions of the CP permissibly and acquired different results.We found an unknown impurity in this sample by HPLC-PDA.The unknown impurity wasn't separated by the current method of CP,and just the unknown impurity made a mistaken sentence.Conclusions:The determination method of related substances in Doxycycline Hyclate Tablets of CP should be improved in the future.

关 键 词：有关物质 中国药典 盐酸多西环素 改变 色谱条件 HPLC 测定方法 变色 杂质 样品 

分 类 号：R927[医药卫生—药学] R921.2