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目的采用HPLC法测定盐酸帕罗西汀中的毒性杂质。方法采用C1 8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0.021~0.210μg·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 determine the toxic impurities in paroxetine hydrochloride by HPLC. Methods The mobile phase consisted of acetonitrile and sodium perchlorate with gradient elution at a flow rate of 1.5 mL · min-1 on a C1 8 column (250 mm × 4.6 mm, 5 μm) with a detection wavelength of 242 nm. Results The toxic impurity peak was separated from the main peak and the impurity peaks. The linear relationship between the toxic impurities 0.021-0.210 μg · mL-1 and the peak area was good (r = 0.9998). The minimum detection limit was 0.126 ng. Conclusion The method is simple, accurate and specific, and can be used for the determination of toxic impurities in paroxetine hydrochloride raw materials.