高效液相色谱法直接拆分度洛西汀  

HPLC direct enantiomeric separation of duloxetine

作　　者：周英珍[1] 王国海[1] 刘秀英[1] 陈建征[1] 

机构地区：[1]江苏恩华药业股份有限公司技术中心,徐州221007

出　　处：《药物分析杂志》2009年第4期641-644,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:采用高效液相色谱法分析手性药物度洛西汀及其R-对映体。方法:以正己烷为流动相,在Chiralcel OD-H手性柱上考察了极性调节剂、酸碱添加剂及柱温对手性分离的影响,确定色谱条件为:柱温35oC,流动相组成正己烷-异丙醇-二乙胺(80∶20∶0.025,v/v/v),流速0.5mL·min-1,检测波长230nm。结果:度洛西汀与其R-对映体的分离度为3.664。结论:此方法能用于度洛西汀对映体含量的分析测定。Objective：To establish an HPLC method for separation of duloxetine and its R-enantiomer.Method：Hexane was used as the mobile phase.The influences of the composition of the mobile phase,the content of acidic and basic additives and the column temperatrures were investigated.The best separation was achieved with hexane-isopropanol-diethylamine mixture （80∶20∶0.025,v/v/v）as the mobile phase,at a flow rate of 0.5 mL·min^-1 at 35 ℃ and UV detection at 230 nm.Results：The resolution of duloxetine and its R-enantiomer was 3.664.Conclusion：This method is applyable to the enantiomeric content control of duloxetine.

关 键 词：高效液相色谱法 手性固定相 度洛西汀对映体 手性分离 

分 类 号：R917[医药卫生—药物分析学]