HPLC测定盐酸帕罗西汀中的毒性杂质

Determination of the toxic impurity of Paroxetine hydrochloride by HPLC

目的 采用HPLC法测定盐酸帕罗西汀中的毒性杂质.方法 采用C18色谱柱（250 mm×4.6 mm,5μm）,流动相为乙腈、高氯酸钠缓冲液,梯度洗脱,流速1.5 mL·min-1,柱温30 ℃,检测波长242 nm.结果 毒性杂质峰与主峰及各杂质峰均能较好地分离,毒性杂质0.021 ～0.210 μg·mL-1与峰面积的线性关系良好（r=0.9998）,最低检测限为0.126 ng.结论 所用方法简便、准确、专属性好,可用于盐酸帕罗西汀原料药中毒性杂质的测定.

OBJECTIVE To establish an HPLC method for determination of the toxic impurity of Paroxetine hydrochloride. METHODS RP- C18 column（250 mm×4.6 mm,5μm） was adopted, and aeetonitrile- sodium perchlorate buffer gradient elution was used as mobile phase. The flow rate was set at 1.5 mL. min - l , the column temperature was set at 30℃, and the wavelength of detector was 242 nm. RESULTS The toxic impurity was completely separated from other impurities. The solution had a good linear relationship ranged from 0. 021 to 0.210 μg·mL-1 （r=0.9998） ,and the LOD was 0. 126 ng. CONCLUSION This method is simple, rapid and sensitive for determination of the toxic impurity in Paroxetine hydrochloride.