一测多评法测定双黄连口服液中4种指标性成分

Simultaneous Determination of Four Index Components in ShuangHuangLian Oral Liquid by QAMS

目的建立同时测定双黄连口服液中4个指标性成分含量的一测多评法。方法采用ZORBAXSB C8(4.6mm×250mm,5μm),流动相为0.8%冰醋酸水溶液-乙腈,梯度洗脱,流速1.0mL·min^-1,检测波长300nm,柱温30℃。以绿原酸为内参物,分别计算与木犀草苷、黄芩苷、连翘苷的相对校正因子,实现一测多评。同时利用外标法和一测多评法测定4个指标性成分的含量,比较两种方法的测定结果是否存在差异。结果一测多评法与外标法测定结果无显著差异。实验所测得的相对校正因子重复性良好。4批不同生产厂家的双黄连口服液样品中绿原酸、木犀草苷、黄芩苷、连翘苷的含量范围分别为1.03~1.56、0.81~1.01、0.50~0.74、0.49~0.54mg·mL^-1。结论一测多评法可以用于双黄连口服液中4个指标性成分的含量测定,且具有可行性与经济性。

OBJECTIVE To establish a method for simultaneous determination of four components in ShuangHuangLian oral liquid.METHODS Using ZORBAXSB C8(4.6 mm×250 mm,5μm),0.8% glacial acetic acid solution-acetonitrile as the mobile phase,The flow rate was 1.0 mL·min^-1,detection wavelength of 300 nm,and the column temperature was 30℃.Taking Chlorogenic acid as internal reference,the relative correction factors of Galuteolin,Forsythin,Baicalin luteolin were calculated respectively,so as to realize one test and multiple evaluation.At the same time,the content of 4 index components was determined by using the external standard method and the one test multiple evaluation method.RESULTS There was no significant difference between the results of the multi-evaluation method and the external standard method.The relative correction factors measured in the experiment have good repeatability.The content ranges of Chlorogenic acid,Galuteolin,Forsythin and Baicalin luteolin in ShuangHuangLian oral liquid samples from 4 batches of different manufacturers were respectively 1.03-1.56 mg·mL^-1,0.81-1.01 mg·mL^-1,0.50-0.74 mg·mL^-1,0.49-0.54 mg·mL^-1.CONCLUSION The method is feasible and economical for the determination of 4 index components in ShuangHuangLian oral liquid.