摘要
目的:建立测定吸入用七氟烷中V、Cr、Co、Ni、Cu、As、Se、Ag、Cd、Ba、Tl、Pb等12种元素杂质含量的方法。方法:样品经适当的前处理,采用电感耦合等离子体质谱法(ICP-MS)以^(45)Sc、^(72)Ge、^(103)Rh、^(115)In、^(209)Bi为内标元素测定12种元素杂质。结果:各元素杂质在1~400 ng/mL范围内线性关系良好(r≥0.9990);检测限为0.0032~1.2350 ng/mL;精密度试验的RSD为0.40%~2.69%;各元素平均加样回收率为91.37%~104.18%(RSD为0.88%~3.83%,n=9)。结论:该方法操作简单、准确,精密度、重复性良好,可用于吸入用七氟烷中多种元素杂质的含量检测,为其风险监控提供参数。
Objective:To establish a method for the contents determination of V,Cr,Co,Ni,Cu,As,Se,Ag,Cd,Ba,Tl,Pb Sevoflurane for Inhalation.Methods:After the samples pretreatment,the elemental impurities were determined by inductively coupledplasma mass spectrometry(ICP-MS)with^(45)Sc、^(72)Ge、^(103)Rh、^(115)In、^(209)Bi as internal standard method.Results:The elemental impurities showed good linear relationship in the range of 1-400 ng/mL(r≥0.9990).The limits of detection were 0.0032-1.2350 ng/mL.RSD of precision were 0.40%-2.69%.The recoveries were 91.37%-104.18%(RSD 0.88%-3.83%,n=9).Conclusion:The method is simple and accurate,precise and reproducible.It can be used for content determination of various elemental impurities in Sevoflurane for Inhalation and provide parameters for its risk monitoring.
作者
陈珍珍
裴昆
程奇珍
常亮
CHEN Zhenzhen;PEI Kun;CHENG Qizhen;CHANG Liang(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China;JiangxiDrug Inspection Center,Jiangxi Vaccine Inspection Center,Nanchang Jiangxi 330029,China.)
出处
《药品评价》
CAS
2021年第11期650-652,共3页
Drug Evaluation
基金
江西省药品监督管理局科研项目(2019JS12)。
关键词
吸入用七氟烷
电感耦合等离子体质谱法
杂质
Sevoflurane for inhalation
Inductively coupled plasma mass spectrometry
Impurities
