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

目的建立电感耦合等离子体质谱法(inductively coupled plasma mass spectrometry,ICP-MS)测定预灌封装依诺肝素钠注射液中23种元素杂质含量的方法。方法样品经消化后,采用ICP-MS,以钇Y、锗Ge、铟In、铋Bi和钪Sc元素为内标,测定10批依诺肝素钠注射液样品中23种元素杂质的含量。结果23种元素线性关系均良好,相关系数r均>0.998,各元素的平均回收率为85.1%~103.4%,RSD<4.9%。结论该方法简便有效,具有良好的灵敏度和准确度,可用于同时测定依诺肝素钠注射液中23种元素杂质含量。

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.