金华栓剂中特征成分的含量测定

Determination of characteristic components in Jinhua suppository

目的测定金华栓剂中特征成分的含量。方法采用HPLC法测量金华栓中西贝碱的含量,GC法测定金华栓中龙脑、异龙脑的含量。HPLC采用Inertsil ODS-SP柱(150 mm×4.6 mm,5μm),流动相为乙腈-0.1%TFA(25∶75),进样量10μL。GC采用聚乙二醇20000为固定相,进样量1μL。结果西贝碱的线性范围为0.125~0.625μg(r^(2)=0.9995),平均加样回收率为84.6%,RSD=3.5%。异龙脑、龙脑的线性范围分别为0.4~1.2、0.6~1.8 mg·mL^(-1),平均加样回收率分别为105.7%、105.6%,RSD分别为2.40%、2.50%。结论所用方法结果准确、专属性好、重复性好,阴性对照无干扰,可为制剂的质量控制提供依据。

OBJECTIVE To detect the characteristic components in Jinhua suppository.METHODS An HPLC method was used to detect sipeimine in Jinhua suppository.Borneol and isoborneol in Jinhua suppository were detected by GC method.HPLC was performed with the Inertsil ODS-SP column(150 mm×4.6 mm,5μm)and the mobile phase consisting of acetonitrile-1%TFA(25∶75).The injection volume was 10μL.GC was performed with polyethylene glycol 20000 as the stationary phase with the injection volume of 1μL.RESULTS The linear range of sipeimine was 0.125-0.625μg(r^(2)=0.9995),and the average recovery was 84.6%with the RSD of 3.5%(n=3).The linear ranges of isoborneol and borneol were 0.4-1.2 mg·mL^(-1)(r^(2)=0.9996)and 0.6-1.8 mg·mL^(-1)(r^(2)=0.9994).The average recoveries for isoborneol was 105.7%with the RSD of 2.40%(n=3),and the average recoveries for borneol was 105.6%with the RSD of 2.50%(n=3).CONCLUSION The methods have high accuracy,good specificity and excellent repeatability,showing no interference from the negative control sample.They can provide the basis for the quality control of Jinhua suppository.