高效液相色谱法测定盐酸度洛西汀肠溶片的R-异构体

Determination of R-isomer in duloxetine hydrochloride enteric-coated tablets by HPLC

目的建立HPLC法测定盐酸度洛西汀肠溶片R-异构体的方法。方法色谱柱:手性AD-H柱(0.46cm×25cm);流动相:正己烷-异丙醇-二已胺(97.8∶2∶0.2),流速:1.0mL·min-1,检测波长:294nm。结果盐酸度洛西汀R-异构体在2.41～48.20μg·mL-1,色谱峰面积与浓度呈良好的线性关系,r=0.9999,盐酸度洛西汀与其R-异构体的分离度达8.52。结论该方法准确度高、专属性强,可用于盐酸度洛西汀的质量控制。

Objective To establish the determination method for R-isomer in duloxetine hydrochloride enteric-coated tablets by HPLC. Methods The analytical column was chiral AD-H column （0. 46 cm× 25 cm）. The mobile phase was n hexane-iso-propanol-diethylamine （97.8 ：2 ： 0.2）. The flow rate was 1.0 mL ·min^-1 and the detective wavelength was 294 nm. Results The calibration curve was linear at 2.41-48. 20 μg · mL^-1 , r=0. 999 9. The resolution between duloxetine hydrochloride and its R-isomer reached 8. 52. Conclusion This method is simple, accurate, sensitive and suitable for the quality control of R-isomer in duloxetine hydrochloride.