基于HPLC测定五味通栓口服液中黄芪甲苷含量的方法学研究

Methodological Study on the Determination of Astragaloside IV in Wuwei Tongshuan Oral Liquid by HPLC

目的:建立HPLC测定五味通栓口服液中黄芪甲苷含量的方法,并与原质量标准中的薄层扫描法进行对比。方法:分别采用薄层扫描法和HPLC测定五味通栓口服液中黄芪甲苷含量,对后者进行方法学考察:使用Venusil XBP-C_(18)(L)色谱柱或ZORBAX SB-C_(18)色谱柱,以乙腈-水(32∶68)为流动相,柱温30.0℃,流速1.0 mL/min,进样量10μL,ELSD检测。结果:HPLC测定黄芪甲苷含量方法的系统适用性、专属性、重复性、准确度、线性、色谱柱耐用性符合规定;对同一样品,薄层扫描法测得含量为0.38 mg/支,本方法为0.8312 mg/支。结论:HPLC测定黄芪甲苷含量的方法较原标准中薄层扫描法准确度更高,重复性更好,简便易行,可作为五味通栓口服液质量控制的方法。

Objective:A HPLC method for the determination of astragaloside IV in Wuwei Tongshuan oral liquid was established and compared with the TLC scanning method in the original quality standard.Methods:The content of astragaloside IV in Wuwei Tongshuan oral liquid was determined by TLC scanning and HPLC respectively,and the methodology of the latter was investigated.Venusil XBP-C_(18)(L)column or ZORBAX SB-C_(18) column was used with acetonitrile-water(32:68)as mobile phase.The column temperature was 30.0 C,and the flow rate was 1.O mL/min.The injection volume was 10μL,and detected with ELSD.Results:The systematic applicability,specificity,repeatability,accuracy,linearity and column durability of the determination of astragaloside IV by HPLC were in accordance with the regulations.For the same sample,the content was determined to be O.38mg/branch by TLC scanning and 0.8312 mg/branch by HPLC.Conclusion:HPLC for the determination of astragaloside IV is more accurate,repeatable and simple than the TLC scanning method,which could be used as a method for quality control of Wuwei Tongshuan oral liquid.