UPLC-MS/MS法同时测定中药注射液中5种生物胺的含量  

Simultaneous determination of five biogenic amines in traditional Chinese medicine injection by UPLC-MS/MS

作　　者：齐越 鄢长余 矫建 赵月然 QI Yue;YAN Changyu;JIAO Jian;ZHAO Yueran(Department of Pharmaceutical Technology,Jiangsu Provincial Xuzhou Pharmaceutical Vocational College,Jiangsu,Xuzhou 221116,China;Dalian Inspection and Certification Technology Service Center,Liaoning,Dalian 116021,China)

机构地区：[1]徐州医药高等职业学校药学技术系,江苏徐州221116 [2]大连市检验检测认证技术服务中心,辽宁大连116021

出　　处：《中国医药科学》2023年第21期71-74,共4页China Medicine And Pharmacy

基　　金：江苏省药品监督管理局科研计划课题(2021041);辽宁省自然科学基金(20170540227)。

摘　　要：目的 建立采用UPLC-MS/MS法同时测定中药注射液中组胺、腐胺、酪胺、色胺、亚精胺等5种生物胺含量的方法。方法 采用Waters ACQUITY UPLC BEH HILIC(100 mm×2.1 mm,1.7 μm)色谱柱,以乙腈-20 mmol/L甲酸铵(甲酸调pH为4.0)为流动相,梯度洗脱,流速0.3 ml/min,柱温40℃。在正离子多反应监测(MRM)模式下测定。结果 各组分在1~200 ng/ml浓度范围内线性关系良好(r>0.999),平均回收率(n=6)在93.5%~98.2%,RSD均在1.0%以内。结论 该方法操作简单,灵敏度高,重复性强,可以用于中药注射液中生物胺的检测。Objective To establish the UPLC-MS/MS method for simultaneous determination of five biogenic amines,including histamine,putrescine,tyramine,tryptamine and spermidine,in traditional Chinese medicine injection.Methods Waters ACQUITY UPLC BEH HILIC(100 mm×2.1 mm,1.7μm)column was adopted,and acetonitrile-20 mmol/L ammonium formate(adjusted to pH 4.0 by formic acid)was used as the mobile phase,and gradient elution was performed at the flow rate of 0.3 ml/min and the column temperature of 40℃.The determination was performed in positive ion multiple reaction monitoring(MRM)mode.Results The linear relationship of each component was good(r>0.999)within the concentration range of 1 to 200 ng/ml,the average recovery(n=6)was 93.5%-98.2%,and the RSD was within 1.0%.Conclusion UPLC-MS/MS method is easy to operate,with high sensitivity and repeatability.Therefore,it can be used for the determination of biogenic amines in traditional Chinese medicine injection.

关 键 词：中药注射液 生物胺 组胺 腐胺 酪胺 色胺 亚精胺 含量测定 超高效液相色谱-串联质谱 

分 类 号：R917[医药卫生—药物分析学]