HPLC法测定盐酸帕罗西汀制剂中三种成分的含量

Determination of three components in paroxetine hydrochloride preparation by HPLC

建立测定盐酸帕罗西汀制剂中盐酸帕罗西汀、去氟帕罗西汀、N-甲基帕罗西汀含量的HPLC测定方法。采用Agilent ZORBAX Eclipse XDB-C18(4.6×150nm,5μm)柱,以磷酸盐缓冲液-乙腈混合液(8:2)为流动相,检测波长295nm,流速1.5ml.min-1,柱温40℃。盐酸帕罗西汀、去氟帕罗西汀、N-甲基帕罗西汀线性范围分别为54~432μg·m L-1、0.112~1.12μg·m L-1、0.0408~0.408μg·m L-1,平均回收率和RSD分别为101.1%、0.6%,100.0%、0.6%,99.7%、1.0%,检出限为0.306~0.448ng。该方法可以快速、简便检测盐酸帕罗西汀制剂中盐酸帕罗西汀、去氟帕罗西汀、N-甲基帕罗西汀含量,对盐酸帕罗西汀制剂质量控制研究有较好的参考价值。

To establish a HPLC method for the determination of paroxetine hydrochloride,defluorinationparoxetine,N-methyparoxetine of paroxetine hydrochloride preparation.Agilent ZORBAX Eclipse XDBC18(4.6×150nm,5μm)column was used for separating samples with Phosphate bufferAcetonitrile mixture(8:2)as mobile phase and detective wavelength was set at 295nm,flow rate was 1.5ml.min-1,column temperature was 40℃The Linear range of paroxetine hydrochloride,defluorinationparoxetine,Nmethyparoxetine were 54~432μg·mL-1、0.112~1.12μg·mL-1、0.0408~0.408μg·mL-1,the average recovery and RSD were 101.1%、0.6%,100.0%、0.6%,99.7%、1.0%respectively,detection limit was 0.306~0.448ng.This method is rapid and simple for content determination of paroxetine hydrochloride,defluorinationparoxetine,N-methyparoxetine,can be used for quality con-trol of paroxetine hydrochloride preparation.