HPLC法测定盐酸达泊西汀中R-异构体含量

Determination of R-Isomer in Dapoxetine Hydrochloride by HPLC

目的:建立盐酸达泊西汀中R-异构体的HPLC检测方法。方法:色谱柱:Phenomenex lux■Cellulose-1(250 mm×4.6 mm,5μm);流动相:正己烷-0.1%二乙胺乙醇溶液(98.5∶1.5);流速:1.0 ml·min^(-1);检测波长:292 nm;进样体积:10μl;柱温:25℃。结果:盐酸达泊西汀在0.2~6.2μg·ml^(-1)浓度范围内线性关系良好(r=1.0000),R-异构体浓度在0.2~5.9μg·ml^(-1)范围内线性关系良好(r=1.0000),R-异构体的校正因子为0.96。R-异构体回收率为100.8%,RSD为2.2%(n=9)。结论:该方法专属性好,精密度和准确度高,可用于盐酸达泊西汀中R-异构体的含量测定。

Objective:To establish an HPLC method for the determination of R-isomer in dapoxetine hydrochloride.Methods:A Phenomenex luxCellulose-1 column(250 mm×4.6 mm,5μm)was used.The mobile phase were composed of n-hexane-0.1%diethylamine ethanol solution(98.5∶1.5),the flow rate was 1.0 ml·min^(-1),the detection wavelength was 292 nm,the injection volume was 10μl and the column temperature was 25℃.Results:The standard curve of dapoxetine hydrochloride showed a good linear relationship over the range of 0.2-6.2μg·ml^(-1)(r=1.0000),and the standard curve of R-isomer showed a good linear relationship over the range of 0.2-5.9μg·ml^(-1)(r=1.0000),and the relative response factor of R-isomer was 0.96.The recovery of R-isomer was 100.8%,and RSD was 2.2%(n=9).Conclusion:The method is suitable for the determination of isomer in dapoxetine hydrochloride with good specificity,precision and accuracy.