ICP-AES和ICP-MS测定脂肪乳类注射液中铝元素含量

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中文摘要：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。36 µg·L-1，方法定量限分别为4。07和1。20 µg·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。

外文标题：Determination of aluminum in fat emulsion injection by ICP-AES and ICP-MS

外文摘要：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,accura-cy,repeatability,detection limit,quantification limit and sample determination results of the two methods by meth-odological verification and determination.Results:The linearity range of two methods were 5-200 μg·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 0.36 μg·L-1.The quantification limit of two methods were 4.07 and 1.20 μg·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.

外文关键词：

ICP-MSICP-MSfat emulsion injectionaluminumdetermination of contentcomparative analysis

作者：

董宇、阚微娜、赵哲、薛娇、王震红

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作者单位：

辽宁省药品检验检测院,沈阳 110036

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

出版年：

2024

DOI：