注射用二羟丙茶碱有关物质的HPLC-QTOFMS分析  

Determination of Related Substances in Diprophylline for Injection by HPLC-QTOF MS

作　　者：任美婷[1] 宋冬梅[1] 江文明[1] 杨永健[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国医药工业杂志》2012年第6期463-465,共3页Chinese Journal of Pharmaceuticals

基　　金：上海市食品药品监督管理局课题(kt-20101101391)资助

摘　　要：建立了高效液相色谱-四极/飞行时间质谱法测定注射用二羟丙茶碱中的有关物质。采用Eclipse plus C18色谱柱,以0.1%甲酸-甲醇(72︰28)为流动相。采用正离子模式采集数据。注射液中共检出4个有关物质,推断分别为茶碱、茶碱与二羟丙茶碱的聚合体、二羟丙茶碱的二聚体及其同分异构体。An HPLC-QTOF MS method was established for the determination of the related substances in diprophylline for injection.A Eclipse plus C18 column was used with the mobile phase of 0.1% formic acid-methanol（72︰28）.The data was acquired in positive ion mode.Four related substances were detected in diprophylline for injection and inferred as theophylline,the polymer of theophylline and diprophylline,diprophylline-dimer and its isomer,respectively.

关 键 词：二羟丙茶碱 有关物质 高效液相色谱-四极/飞行时间质谱 

分 类 号：TQ460.72[医药卫生—药物分析学] O657.72[化学工程—制药化工]