HPLC法测定盐酸度洛西汀原料药及其片剂中杂质R-异构体的含量  

Determination of R-Isomer Content in Duloxetine Hydrochloride Raw Material and Tablets by HPLC

作　　者：李语如[1] 蒋素梅[1] 周云曙[1] 刘钦伟[1] 顾萍[2,3] 

机构地区：[1]江苏恒瑞医药股份有限公司,连云港市222002 [2]江苏豪森药业股份有限公司,连云港市222006 [3]中国药科大学,南京市210009

出　　处：《中国药房》2009年第16期1259-1260,共2页China Pharmacy

摘　　要：目的:建立以高效液相色谱法测定盐酸度洛西汀原料药及其片剂中杂质R-异构体含量的方法。方法:色谱柱为Chiralcel OD-RH;流动相为0.05mol.L-1的六氟磷化钾溶液-乙腈(50∶50),流速为1.0mL·min-1,检测波长为290nm,进样量为10μL。结果:盐酸度洛西汀与其R-异构体分离良好,盐酸度洛西汀检测浓度的线性范围为0.202～201.8μg.mL-1(r=0.9999),R-异构体的平均回收率为99.2%(RSD=1.83%),二者最低检测限均为0.6ng。结论:本方法简便、快速、准确,可用于盐酸度洛西汀原料药及其片剂中R-异构体的含量测定。OBJECTIVE： To establish an HPLC method for the determination of R - isomer content in duloxetine hydrochloride raw material and tablets. METHODS： The determination was performed on Chiralcel OD - RH column with 0.05 mol·L^-1 potassium hexafluorophosphate solution - acetonitrile （50 ： 50） used as mobile phase at a flow rate of 1.0 mL·min^-1. The detection wavelength was set at 290 nm and the sample size was 10uL. RESULTS： Duloxetine hydrochloride and the R - isomer were well - separated. The linear range of duloxetine hydrochloride was 0.202-201.8ug·mL^-1 （ r ： 0.999 9） with the average recovery of R- isomer at 99.2% （RSD = 1.83% ）. The lowest detection limit was 0.6 ng for both duloxetine hydrochloride and the R- isomer. CONCLUSION： This method is proved to be simple, rapid, accurate, and suitable for the determination of R - isomer content in duloxetine hydrochloride raw material and tablets.

关 键 词：高效液相色谱法 盐酸度洛西汀 R-异构体 含量测定 

分 类 号：R727.2[医药卫生—儿科]