摘要
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.
出处
《华西药学杂志》
CAS
CSCD
北大核心
2013年第5期519-520,共2页
West China Journal of Pharmaceutical Sciences