HPLC法同时测定复方四嗪利血平片中盐酸肼屈嗪、维生素B 6和磷酸氯喹的含量及含量均匀度

Simultaneous determination of the content and content uniformity of hydralazine hydrochloride,vitamin B 6 and chloroquine phosphate in Compound Tatrazin and Reserpine Tablets by HPLC

目的建立能同时测定复方四嗪利血平片中盐酸肼屈嗪、维生素B 6和磷酸氯喹的含量及含量均匀度的HPLC法。方法采用Agilent Zorbax Eclipse XDB C 18色谱柱(250 mm×4.6 mm,5μm);以0.06 mol·L^-1磷酸二氢钾溶液-甲醇(90∶10,pH值为3.0)为流动相A,乙腈为流动相B,梯度洗脱;流速为1.0 mL·min^-1;柱温为30℃;检测波长为271 nm。结果系统适用性实验均符合要求,各成分间的分离度均大于1.5,盐酸肼屈嗪、维生素B 6和磷酸氯喹的线性范围分别为19.40~58.20(r 2=0.9999),21.42~64.27(r 1=1.0000)和50.73~152.19μg·mL^-1(r 3=0.9999);平均回收率分别为99.09%,100.99%和99.50%,RSD值分别为1.1%,1.1%和1.2%(n=9)。结论该方法可同时测定复方四嗪利血平片中盐酸肼屈嗪、维生素B 6和磷酸氯喹的含量及含量均匀度,为该产品的质量控制提供参考。

Objective To establish an HPLC method for the content determination and content uniformity of hydralazine hydrochloride,vitamin B 6 and chloroquine phosphate in Compound Tatrazin and Reserpine Tablets.Methods The Agilent Zorbax Eclipse XDB C 18 column(250 mm×4.6 mm,5μm)was used for the separation with 0.06 mol·L^-1 potassium dihydrogen phosphate solution-methanol(90∶10,pH 3.0)(A)and acetonitrile(B)as the mobile phase at a flow rate of 1.0 mL·min-1 in gradient mode.The column temperature was maintained at 30℃and detection wavelength was set at 271 nm.Results The system suitability test met the requirements,and the resolutions factors were all greater than 1.5.The linear ranges of hydralazine hydrochloride,vitamin B 6 and chloroquine phosphate were 19.40-58.20(r 2=0.9999),21.42-64.27(r 1=1.0000)and 50.73-152.19μg·mL^-1 respectively(r 3=0.9999).The average recovery rates were 99.09%,100.99%and 99.50%respectively,RSD were 1.1%,1.1%and 1.2%(n=9)respectively.Conclusion The established method can be applied in the simultaneous determination of the content and content uniformity of hydralazine hydrochloride,vitamin B 6 and chloroquine phosphate in Compound Tatrazin and Reserpine Tablets and provides a reference for quality control.