UPLC-MS/MS法测定再造丸中的4种马兜铃酸类成分  

Determination of four aristolochic acid components in Zaizao pills by UPLC-MS/MS

作　　者：何成军 王颖 陈芳毅 苟琰 耿昭 钟恋 何筱毅 杨蕾 戴忠[3] HE Chengjun;WANG Ying;CHEN Fangyi;GOU Yan;CENG Zhao;ZHONG Lian;HE Xiaoyi;YANG Lei;DAI Zhong(NMPA Key Laboratory of Quality Evaluation of Chinese Patent Medicines,Sichuan Institute for Drug Control,Chengdu,Sichuan,611731 P.R.China;Southwest Pharmaceutical Co.,Ld.,Chongqing,400038 P.R.China;National Institutes for Food and Drug Control,Bejing,100050 P.R.China)

机构地区：[1]四川省药品检验研究院,国家药品监督管理局中成药质量评价重点实验室,四川成都611731 [2]西南药业股份有限公司,重庆400038 [3]中国食品药品检定研究院,北京100050

出　　处：《华西药学杂志》2024年第4期456-459,共4页West China Journal of Pharmaceutical Sciences

基　　金：国家药典委员会“含细辛中成药标准修订”资助项目(2021Z16)。

摘　　要：目的采用超高效液相色谱-串联质谱法测定再造丸中马兜铃酸Ⅰ、马兜铃酸Ⅱ、马兜铃酸Ⅲ、马兜铃内酰胺Ⅰ的含量。方法采用WatersAcquityBEHUPLCC_(18)色谱柱(100mm×2.1mm,1.7μm),以甲醇-0.1%甲酸溶液(含5mmol·L^(-1)甲酸铵)为流动相,梯度洗脱,流速0.3mL·min^(-1),采用电喷雾离子源,正离子模式下,多反应监测模式下,用外标法定量。结果4种马兜铃酸类成分在各自浓度范围内的线性关系良好(r>0.9990),平均加样回收率为88.4%~102.5%,RSD均小于5%。结论所用方法的专属性好、灵敏度高、结果准确,可为再造丸的质量控制提供参考。OBJECTIVE To determine the aristolochic acid I,aristolochic acid II,aristolochic acid II and aristolactam I in Zaizao pills by UPLC-MS/MS method.METHODS The chromatography was performed on Waters Acquity BEH UPLC C_(18)column(100 mm×2.1 mm,1.7μm)with methanol and 0.1%formic acid aqueous solution(containing 5 mmol·L^(-1)ammonium formate)at a gradient elution rate of O.3 mL·min^(-1).The quantitative analysis was carried out by external standard method in multiple reaction monitoring mode with positive electrospray ionization.RESULTS The 4 aristolochic acids components showed good linearity in the range of test concentration,with correlation coefficients greater than 0.9990.The average recoveries were between 88.4%and 102.5%,with RSD less than 5%.CONCLUSION The established method is simple,sensitive,accurate,which can provide reference for the quality control of Zaizao pills.

关 键 词：再造丸 马兜铃酸Ⅰ 马兜铃酸Ⅱ 马兜铃酸Ⅲ 马兜铃内酰胺Ⅰ 超高效液相色谱-串联质谱 多反应监测 

分 类 号：R917[医药卫生—药物分析学]