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目的建立HPLC法测定六味生物制剂有效组分片剂中马钱苷含量。方法采用Ultimate Platisil C18色谱柱(250mm×4.6 mm,5μm),以乙腈-水(15∶85)为流动相,流速为1.0ml·min-1,检测波长236 nm,柱温为35℃。结果马钱苷在质量浓度为50~350μg·ml-1内与峰面积呈良好的线性关系(r=1),平均回收率(n=6)为98.8%,RSD为2.3%。结论该方法专属性强,快速简便,可作为六味生物制剂有效组分片剂中马钱苷含量测定的方法,为六味生物制剂有效组分片剂的质量控制提供参考。
Objective To establish an HPLC method for the determination of loganin in the active ingredient tablets of Liuwei biological preparation. Methods The column was mounted on a Ultimate Platisil C18 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-water (15:85) at a flow rate of 1.0 ml · min-1 with a detection wavelength of 236 nm and a column temperature of 35 ° C. Results Loganin had a good linear relationship with the peak area (r = 1) in the mass concentration of 50 ~ 350μg · ml-1. The average recovery was 98.8% (n = 6) and the RSD was 2.3%. Conclusion The method is specific, rapid and simple, and can be used as a method for the determination of the content of loganin in the effective component tablet of Liuwei biological preparation. It provides a reference for the quality control of the effective component tablet of Liuwei biological preparation.