十三味疏肝胶囊中马兜铃酸A的检测方法研究  

Determination of Aristolochic Acid A in Shisanwei Shugan Capsules

作　　者：黄晓燕 李荣玮 曾蒲军 梁晟 李瑞莲 HUANG Xiaoyan;LI Rongwei;ZENG Pujun;LIANG Sheng;LI Ruilian(Hunan Institute for Drug Control,Changsha Hunan 410001,China)

机构地区：[1]湖南省药品检验研究院,湖南长沙410001

出　　处：《药品评价》2021年第23期1421-1423,共3页Drug Evaluation

基　　金：湖南省科技厅2020年度自然科学基金科药联合基金项目(2020JJ9032)。

摘　　要：目的:建立十三味疏肝胶囊中马兜铃酸A的专属性检测方法。方法:采用超高效液相色谱法(UHPLC-PDA)对十三味疏肝胶囊中马兜铃酸A进行含量测定,并采用液相色谱-质谱联用(LC-MS)对测定结果进行进一步验证。结果:建立的UHPLC-PDA法中,马兜铃酸A在1.999~49.994 ng/mL(r=0.9999)范围内线性关系良好,平均回收率为93.4%(RSD=1.35%),精密度及方法重复性均良好。UHPLC-PDA法可准确检出马兜铃酸A,与LC-MS法的验证结果一致。结论:UHPLC-PDA测定方法准确、重复性好、专属性强,可为十三味疏肝胶囊的质量控制提供参考。Objective:To establish an analytical method for determination of aristolochic acid A in shisanwei shugan capsules.Methods:UHPLC-PDA was used to determine the content of aristolochic acid A.LC-MS was used to verify the results.Results:The linear range of aristolochic acid A was 1.999 to 49.994 ng/mL(r=0.9999),the average recovery rate was 93.4%,and RSD was 1.35%.Precision of the instrument and repeatability of the method were good.Aristolochic acid A can be accurately detected by UHPLC-PDA,which was consistent with the verification results of LC-MS.Conclusion:The methods are highly accurate,specific and reliable,which can provide a reference for the quality control of shisanwei shugan capsules.

关 键 词：中草药 十三味疏肝胶囊 马兜铃酸A 超高效液相色谱 高效液相色谱-质谱 

分 类 号：R286.0[医药卫生—中药学]