HPLC法检查盐酸托莫西汀左旋异构体的有关物质  

Determination of the Related Substances of Atomoxetine Hydrochloride Levamisole Isomer by HPLC

作　　者：陈杰[1] 李展[1] 

机构地区：[1]河南省食品药品检验所,郑州450003

出　　处：《中国药房》2014年第45期4299-4301,共3页China Pharmacy

摘　　要：目的 ：建立盐酸托莫西汀左旋异构体有关物质的检查方法。方法：采用高效液相色谱法。色谱柱为CHIRALPAK~ OT（＋）,流动相为甲醇-异丙醇-三乙胺（960∶40∶0.5）,检测器为蒸发光散射检测器,漂移管温度为90℃,气流速度为2.5 L/min。结果：各杂质峰与主成分峰分离度良好,已知杂质D-ATM、3-ATM、4-ATM与盐酸托莫西汀峰的相对保留时间分别约为0.65、1.26、1.50,前三者检测限分别为0.002 2、0.004 1、0.003 9μg;3批样品中检出D-ATM,未检出3-ATM和4-ATM。结论：建立了盐酸托莫西汀中包括旋光异构体及同分异构体在内的有关物质的检查方法,且方法操作简便、专属性好。OBJECTIVE： To establish a method for the detection of related substances in atomoxetine hydrochloride levamisole isomer. METHODS： HPLC method was adopted. The determination was performed on CHIRALPAK OT（＋） column with mobile phase consisted of methanol-isepropyl alcohol- triethylamine（960 ： 40 ： 0.5）. ELSD detector was used, and the temperature of drift pipe was 90℃; flow rate was 2.5 L/min. RESULTS： The impurity peak was well separated from main component peak; the relative retention time of known impurity D-ATM, 3-ATM, 4-ATM and atomoxetine hydrochloride were 0.65, 1.26 and 1.50, respectively. The detection limits were 0.002 2, 0.004 1 and 0.003 9 lag, respectively. D-ATM was found in 3 batches of sample, while 3-ATM and 4-ATM were not. CONCLUSIONS： The method has been established for the determination of the related substances as optical isomer and isomer in atomoxetine hydrochloride. The method is simple and specific.

关 键 词：盐酸托莫西汀 左旋异构体 HPLC 蒸发光散射检测器 有关物质 分离 检查 

分 类 号：R927[医药卫生—药学]