电感耦合等离子体质谱法测定盐酸溴己新葡萄糖注射液中29种元素杂质含量  

Content determination of 29 element impurities by inductively coupled plasma-mass spectrometry in bromhexine hydrochloride and glucose injection

作　　者：赵冯 张杞柳 陈辉 张磊 ZHAO Feng;ZHANG Qiliu;CHEN Hui;ZHANG Lei(Xuzhou Inspection Testing Center,Xuzhou,Jiangsu 221000,China)

机构地区：[1]徐州市检验检测中心,江苏徐州221000

出　　处：《安徽医药》2024年第1期36-40,共5页Anhui Medical and Pharmaceutical Journal

基　　金：江苏省市场监督管理局科技计划项目(KJ21125019)。

摘　　要：目的建立利用电感耦合等离子体质谱法(ICP−MS)同时测定盐酸溴己新葡萄糖注射液中29种元素杂质含量的分析方法。方法自2022年9—10月,采用ICP-MS法。样品直接稀释后分析,通过在线加入内标元素来校正测量结果。内标液添加异丙醇进行基质匹配以减少仪器信号漂移干扰和样品基体效应。射频功率1550 W;雾化气流量1.05 L/min;辅助气流量0.90 L/min;KED模式;碰撞气流量4.5 mL/min;全定量法采集。结果29个元素在各自的检测浓度范围内线性关系良好(r>0.9987)。检测限为0.0000573~0.285μg/L,平均回收率为91.0%~108.4%(n=3),重复性为1.3%~7.2%(n=6)。结论该方法快速、准确、操作简便,可用于盐酸溴己新葡萄糖注射液中元素杂质的质量控制。Objective To develop a method for simultaneous content determination of 29 elemental impurities in bromhexine hydro⁃chloride and glucose injection by inductively coupled plasma-mass spectroscopy(ICP-MS).Methods From September to October 2022,ICP-MS method was adopted.Samples were analyzed after direct dilution,measurement results were corrected by adding internal standard elements online.The internal standard solution was supplemented with 2-propanol for matrix matching to reduce the signal drift and the interference of matrix effect.RF power was set at 1550 W;the nebulizer gas flow was set at 1.05 L/min;auxilliary gas flow was set at 0.90 L/min;KED mode;collision gas flow was set at 4.5 mL/min.The data were collected by quantitative method.Results The 29 elements showed good linearity in the specified concentration range with the correlation coefficients(r)being all above 0.9987.Detection limits were 0.0000573-0.285μg/L.The average recoveries were 91.0%-108.4%(n=3).The repeatability was 1.3%-7.2%(n=6).Conclusion The method is rapid,accurate and simple,and applicable for the elemental impurity control of bromhexine hydrochlo⁃ride and glucose injection.

关 键 词：药物污染 盐酸溴己新葡萄糖注射液 电感耦合等离子体质谱法 国际药典委员会Q3D元素杂质指导原则 元素杂质 基质匹配 

分 类 号：O657.63[理学—分析化学] R927.2[理学—化学]