HPLC法分离测定枸橼酸托瑞米芬的E-异构体  

Separation and Determination of E-Isomer in Toremifene Citrate by HPLC

作　　者：黄巧巧[1] 左锋 

机构地区：[1]浙江省药品检验所,杭州310004 [2]宁波天衡制药有限公司

出　　处：《中国药品标准》2007年第5期54-55,共2页Drug Standards of China

摘　　要：目的:建立HPLC法测定枸橼酸托瑞米芬杂质E-异构体的含量。方法:采用以三十烷基硅烷键合硅胶为固定相的色谱柱,0.5%三乙胺溶液(用磷酸调节pH值至3.0)-乙腈-四氢呋喃(55∶40∶5)为流动相,检测波长为240nm。结果:E-异构体最低检出限为5ng。结论:方法简便、高效、快速,为枸橼酸托瑞米芬杂质E-异构体的测定提供了一种新方法。Objective：An HPLC method for determination of E-isomer as impurity in Toremifene Citrate was established. Method：A column with C30 as stationary phase was used with mobile phase of 0.5% triethylamine （pH3. 0）-acetonitrile-tetrahydrofuran （55 ： 40 ： 5）,at the detection wavelength of 240nm. Results：The detection limit of E-isomer was 5nm. Conclusion.-The established method is suitable to analyse E-isomer of Toremifene Citrate due to its advantages of high performance, high speed and easy operation.

关 键 词：HPLC法 枸橼酸托瑞来芬 E-异构体 

分 类 号：R979.1[医药卫生—药品] R978.11[医药卫生—药学]