ICP-MS法测定盐酸阿芬太尼注射液中25种元素杂质的含量
Determination of 25 elements impurities in alfentanil hydrochloride injection by ICP-MS
高梓真 1李磊 1许如玲 1许向阳1
作者信息
- 1. 江苏恩华药业股份有限公司,徐州 221100
- 折叠
摘要
目的:建立电感耦合等离子体质谱法(ICP-MS),测定盐酸阿芬太尼注射液中25种具有潜在风险的元素杂质的含量.方法:采用Agilent 7800 ICP-MS电感耦合等离子体质谱仪,运用常规调谐模式,射频功率1 550 W,等离子气体流量15 L·min-1,通过外标方式消除基质效应,样品稀释直接进样测定.结果:该方法能同时测定25种元素杂质含量,其线性关系良好(r＞0.99),重复性试验的RSD≤10％(n=6),回收率在80.0％～120.0％(n=9),均满足方法学验证的要求.结论:盐酸阿芬太尼注射液元素杂质含量均低于ICH·Q3D规定限度的30％,不会给药品带来安全性风险,本法为其他相似药品元素杂质的质量控制和风险评估提供了参考.
Abstract
Objective:To establish an inductively coupled plasma mass spectrometry(ICP-MS)method for the determination of 25 potentially risky elemental impurities in alfentanil hydrochloride injection.Methods:The Agi-lent 7800 ICP-MS inductively coupled plasma mass spectrometer was used,the conventional tuning mode was used,the RF power was 1 550 W,the plasma gas flow rate was 15 L·min-1,the matrix effect was eliminated by external standard,and the sample was diluted for direct injection.Results:The method can simultaneously deter-mine the content of 25 kinds of elemental impurities,and its linear relationship was good(r＞0.99).The RSD of the repeatability test was ≤10％(n=6),and the recovery rate was 80.0％-120.0％(n=9),all of which met the requirements of methodological validation.Conclusion:The content of elemental impurities in alfentanil hydro-chloride injection is lower than 30％of the limit specified in ICH·Q3D,which will not bring safety risks to the drug,providing a reference for the quality control and risk assessment of elemental impurities in other similar drugs.
关键词
盐酸阿芬太尼注射液/电感耦合等离子体质谱法/元素杂质/方法学验证/含量测定/杂质限度Key words
alfentanil hydrochloride injection/inductively coupled plasma mass spectrometry/element impurities/methodology validation/content determination/impurity limit引用本文复制引用
基金项目
江苏省中枢神经药物研究重点实验室资助项目(BM2019004)
出版年
2024
NETL
NSTL
万方数据