电感耦合等离子体质谱法测定人促红素注射剂中13种杂质元素

Determination of 13 elemental impurities in human erythropoietin injections by inductively coupled plasma mass spectrometry

建立了电感耦合等离子体质谱法测定人促红素注射剂中Cd、Hg、Pb、As、Co、V、Ni、Sb、Mo、Cu、Cr、Al、Fe共13种杂质元素含量。以Sc、In、Ge为内标,采用ICP-MS法测定,等离子体射频功率为1549 W,载气流量为1.12 L/min。Al、Fe质量浓度在0~50 ng/mL范围内、其余11种元素质量浓度在0~10 ng/mL范围内线性关系良好,相关系数均不小于0.999,样品加标平均回收率为81.5%~118.0%,测定结果的相对标准偏差为1.10%~2.82%(n=6),各元素检出限为0.0015~1.1488 ng/g。不同厂家的人促红素注射剂中13种杂质元素的含量均符合ICH规定。该方法准确性好,灵敏度高,可同时测定多种元素,适用于人促红素注射剂中杂质元素的质量控制。

A method of inductively coupled plasma mass spectrometry(ICP-MS)was used to determine 13 elemental impurities such as Cd,Hg,Pb,As,Co,V,Ni,Sb,Mo,Cu,Cr,Al and Fe in Human Erythropoietin Injections.Sc,In and Ge were chosen as internal standard elements,and an ICP-MS method was adopted with following conditions:The RF power of plasma was 1549 W and carrier gas was set at 1.12 L/min.The concentration of Al and Fe in the range of 0-50 ng/mL and the concentration of other 11 elements in the range of 0-10 ng/mL had a good linear relationship,and the correlation coefficients of 13 elemental impurities were all more than 0.999 in their linear ranges..The average recoveries of accuracy of 13 elemental impurities were 81.5%-118.0%,the relative standard deviation was 1.10%-2.82%(n=6),and the detection limits were between 0.0015-1.1488 ng/g.The contents of 13 elemental impurities in human erythropoietin injections from different manufacturers comply with ICH requirement.The established method is accurate and sensitive,which can be used for the elemental impurity control of Human Erythropoietin Injections.