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目的建立盐酸达泊西汀片剂中异构体的HPLC检测方法。方法采用DAICEL CHIRALPAK OZ-H色谱柱(250mm×4.6 mm,5μm),柱温:40℃,检测波长:293 nm,流速:1.0 m L·min-1,流动相:正己烷-异丙醇-二乙胺(80∶20∶0.05)。结果盐酸达泊西汀及其异构体在0.01~0.50 mg·mL~(-1)内具有良好的线性关系(r=0.999 9),盐酸达泊西汀定量限为0.002 mg·mL~(-1)(相当于0.02%),最低检测限为0.001 mg·mL~(-1)(相当于0.01%);异构体定量限浓度为0.001 mg·mL~(-1)(相当于0.01%),最低检测限为0.000 5 mg·mL~(-1)(相当于0.005%)。结论该方法操作简便,结果准确,可用于盐酸达泊西汀片剂中异构体的含量测定。
Objective To establish an HPLC method for the determination of isomers of Dapsoxetine Hydrochloride Tablets. Methods The analytical column was DAICEL CHIRALPAK OZ-H (250 mm × 4.6 mm, 5 μm). The column temperature was 40 ℃, the detection wavelength was 293 nm and the flow rate was 1.0 mL · min-1. The mobile phase was n-hexane- Diethylamine (80:20:0.05). Results Dapoxetine hydrochloride and its isomers had a good linearity (r = 0.999 9) in the range of 0.01-0.50 mg · mL -1, and the limit of quantification of Dapoxetine hydrochloride was 0.002 mg · mL -1 -1) (equivalent to 0.02%). The limit of detection was 0.001 mg · mL -1 (corresponding to 0.01%). The limit of quantification was 0.001 mg · mL -1 (corresponding to 0.01 %). The lowest detection limit was 0.000 5 mg · mL -1 (equivalent to 0.005%). Conclusion The method is simple, accurate and can be applied to the determination of isomers in Dapoxetine hydrochloride tablets.