ICP-MS法测定碳青霉烯类抗生素药物中的12种元素杂质  

Determination of 12 Elemental Impurities in Carbapenems Antibiotics by ICP-MS

作　　者：王茉莉 陈饶 张浩 李聪颖 WANG Moli;CHEN Rao;ZHANG Hao;LI Congying(Hebei Institute of Drug and Medical Device Inspection and Research,Shijiazhuang 050020,China)

机构地区：[1]河北省药品医疗器械检验研究院,河北石家庄050020

出　　处：《生物化工》2025年第1期153-157,共5页Biological Chemical Engineering

基　　金：2022年度河北省药品监督管理局科技计划项目(2022ZC1031)。

摘　　要：目的:为解决现有方法的局限性,采用电感耦合等离子质谱法测定碳青霉烯类抗生素药物中的锂、钒、镍、钴、铜、砷、铑、钯、镉、锑、汞、铅12种元素。方法:以高纯氩气为载气,以高纯氦气为碰撞气,采用普通进样模式。射频功率1550 W,氦气流量5.0 mL/min,雾化气流速1.08 L/min,采样深度10 mm,雾化室温度2.0℃;泵速0.3 r/s;分析模式:全定量,每个样品测定5次,内标在线加入。结果:12种元素的回收率在79.25%~128.97%;检出限在0.0010~0.1237 ng/mL,能够满足痕量检测要求;实际样品检测结果发现各元素均符合限度要求。结论:该方法专属性强、灵敏度高、检测限低、准确度好,可同时测定多种元素,可用于检测碳青霉烯类抗生素药物中的元素杂质含量。Objective:To address the limitations of existing methods,and determine the contents of 12 elements(lithium,vanadium,nickel,cobalt,copper,arsenic,rhodium,palladium,cadmium,antimony,mercury and lead)in carbapenem antibiotic drugs using inductively coupled plasma mass spectrometry.Methods:A high-purity argon gas is used as the carrier gas,and a high-purity helium gas is used as the collision gas.The normal injection mode is used.The RF power is 1550 W,the helium gas flow rate is 5.0 mL/min,the atomization gas flow rate is 1.08 L/min,the sampling depth is 10 mm,the atomization chamber temperature is 2.0℃;the pump speed is 0.3 r/s;the analysis mode is full quantitative,and each sample is measured five times with an internal standard added in-line.Results:The recovery of the 12 elements is within the range of 79.25%to 128.97%;the detection limits are within the range of 0.0010 ng/mL to 0.1237 ng/mL,which could meet the requirements for trace detection.Conclusion:The method has the advantages of strong specificity,high sensitivity,low detection limit,and good accuracy,and can simultaneously determine the elemental impurities in carbapenem antibiotic drugs.

关 键 词：电感耦合等离子质谱法 碳青霉烯类抗生素 元素杂质 

分 类 号：O657.63[理学—分析化学]