【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。更多还原

【Abstract】 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 10 μL.RESULTS:Duloxetine hydrochloride and the R-isomer were well-separated.The linear range of duloxetine hydrochloride was 0.202～201.8 μg·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.更多还原