超高效液相色谱-四级杆静电场轨道阱高分辨质谱法同时测定中药液体制剂塑料包装中37种添加剂的迁移量  

Simultaneous determination of 37 additives in plastic packaging of Chinese medicine liquid preparations by ultra high performance liquid chromatography quadrupole orbitrap highresolution mass spectrometry

作　　者：倪倩 熊菲 田京歌 孙彦敏 周娟娟 张妤琳 庞庆林 NI Qian;XIONG Fei;TIAN Jingge;SUN Yanmin;ZHOU Juanjuan;ZHANG Yulin;PANG Qinglin(Jiangsu Institute for Food and Drug Control,Nanjing 210019,China;China Pharmaceutical University,School of Pharmacy,Nanjing 211198,China)

机构地区：[1]江苏省食品药品监督检验研究院,南京210019 [2]中国药科大学药学院,南京211198

出　　处：《化学分析计量》2024年第11期33-39,57,共8页Chemical Analysis And Meterage

基　　金：江苏省市场监督管理局科研计划项目(KJ2023028)。

摘　　要：建立了超高效液相色谱-四级杆-静电场轨道阱高分辨质谱法同时测定中药液体制剂塑料包装中37种添加剂的迁移量。以甲醇-乙腈(体积比为1∶1)和水作为流动相进行梯度洗脱,流量为0.35mL/min,柱温为35℃,采用目标母离子二级扫描模式进行监测。37种添加剂在对应的质量浓度范围内与色谱峰面积线性关系良好,相关系数均不小于0.995,方法检出限为0.002~0.01mg/L。37种添加剂迁移量的平均回收率为80.2%~117.6%,测定结果的相对标准偏差为1.4%~9.0%(n=6)。该方法简单、灵敏、准确,适用于中药液体制剂塑料包装中37种添加剂迁移量的检测。An ultra high performance liquid chromatography quadrupole orbitrap high-resolution mass spectrometry method was established to simultaneously determine 37 additives.Methanol acetonitrile(volume ratio 1:1)and water were used as mobile phase for gradient elution,the flow rate was 0.35 mL/min,the column temperature was 35℃,and the target parent ions were monitored in the secondary scanning mode.The 37 additives had a good linear relationship with chromatographic peak area in the corresponding mass concentration range,and the correlation coefficient was no less than 0.995.The detection limits of the method were 0.002-0.01 mg/L.The average recoveries of 37 additives were 80.2%-117.6%,and the relative standard deviations were 1.4%-9.0%(n=6).The method is simple,sensitive and accurate,which is suitable for the detection of 37 additives in the plastic packaging of traditional Chinese medicine liquid preparation.

关 键 词：超高效液相色谱-四级杆-静电场轨道阱高分辨质谱法 中药液体制剂塑料包装 塑料添加剂 迁移量 

分 类 号：O657.7[理学—分析化学]