ICP-AES和ICP-MS测定脂肪乳类注射液中铝元素含量  

Determination of aluminum in fat emulsion injection by ICP-AES and ICP-MS

作　　者：董宇 阚微娜 赵哲 薛娇 王震红 DONG Yu;KAN Weina;ZHAO Zhe;XUE Jiao;WANG Zhenhong(Liaoning Institute for Drug Control,Shenyang 110036,China)

机构地区：[1]辽宁省药品检验检测院,沈阳110036

出　　处：《中国药品标准》2024年第6期612-617,共6页Drug Standards of China

基　　金：辽宁省检验检测认证中心创新创业项目(SC20210115)。

摘　　要：目的:建立电感耦合等离子体原子发射光谱法(ICP-AES)和电感耦合等离子体质谱法(ICP-MS)测定脂肪乳类注射液中铝元素杂质含量的方法,并比较两者的差异。方法:通过方法学验证及样品的测定,对2种方法的线性、准确度、重复性、检测限、定量限和测定结果进行对比分析。结果:2种方法的铝离子浓度在5~200μg·L^(-1)范围内呈良好的线性关系,相关系数均大于0.999,加样回收率平均值分别为103.0%、106.7%、103.2%(n=9)和99.8%、106.5%、100.8%(n=9);重复性试验结果RSD均为2.0%(n=9),方法检出限分别为1.22和0.36μg·L^(-1),方法定量限分别为4.07和1.20μg·L^(-1),8批脂肪乳类注射液样品的铝元素杂质测定结果基本一致。结论:上述两种方法操作简单、灵敏,准确度高、重现性好,均可用于脂肪乳类注射液中铝元素杂质的含量测定。Objective:To establish ICP-AES and ICP-MS methods for determination of aluminum impurities in fat emulsion injection and compare the difference between the two methods.Methods:Compare the linearity,accuracy,repeatability,detection limit,quantification limit and sample determination results of the two methods by methodological verification and determination.Results:The linearity range of two methods were 5-200μg·L^(-1),the correlation coefficients were greater than 0.999,the average recovery were 103.0%,106.7%,103.2%(n=9)and 99.8%,106.5%,100.8%(n=9),The RSD of reproducibility both were 2.0%,the detection limit of two methods were 1.22 and 0.36μg·L^(-1).The quantification limit of two methods were 4.07 and 1.20μg·L^(-1).The contents of aluminum impurities in 8 batches of fat emulsion injection were basically the same.Conclusion:The two methods were convenient,sensitive,accurate and good repeatability,which can be used for the determination of aluminum impurities in fat emulsion injection.

关 键 词：电感耦合等离子体原子发射光谱法 电感耦合等离子体质谱法 脂肪乳注射液 铝元素 含量测定 对比分析 

分 类 号：R921.2[医药卫生—药学]