中国药物经济学2024，Vol.19Issue(10)：104-108,5.DOI:10.12010/j.issn.1673-5846.2024.10.021
电感耦合等离子体质谱法测定预灌封装依诺肝素钠注射液中23种元素的含量
Determination of 23 Elemental impurities in Pre-filled Enoxaparin Sodium Injection by ICP-MS
摘要
Abstract
Objective To establish an inductively coupled plasma mass spectrometry(ICP-MS)method for the determination of 23 elemental impurities in pre-filled enoxaparin sodium injection.Methods After digestion,the ICP-MS method was used with Y,Ge,In,Bi,and Sc as internal standards to determine the content of 23 elemental impurities in three batches of the enoxaparin sodium injection samples.Results The linear relationship of the 23 elements was good,with correlation coefficients r＞0.993.The average recoveries of the elements ranged from 85.1%to 103.4%,with RSD＜4.9%.Conclusion The method is simple and effective,with good sensitivity and accuracy.It can be used for the simultaneous determination of 23 elemental impurities in enoxaparin sodium injection and can serve as a reference for the quality control and risk assessment of elemental impurities in similar pharmaceutical products.关键词
电感耦合等离子体质谱法/预灌封装依诺肝素钠注射液/元素含量Key words
Inductively coupled plasma mass spectrometry/Pre-filled E noxaparin sodium injection/Elemental content分类
医药卫生引用本文复制引用
付金凤,张岩琛,刘晓强,欧阳芳欣,黄强燕..电感耦合等离子体质谱法测定预灌封装依诺肝素钠注射液中23种元素的含量[J].中国药物经济学,2024,19(10):104-108,5.基金项目
江苏省药品监督管理局2022年科研项目(202243) （202243）
