| 引用本文: | 阚微娜,王棘,陈默,王全一,杨宏伟.复方氨基酸类注射液中铝元素3种测定方法的比较[J].中国现代应用药学,2021,38(24):3122-3126. |
| KAN Weina,WANG Ji,CHEN Mo,WANG Quanyi,YANG Hongwei.Comparison of Three Determination Methods of Aluminum in Compound Amino Acid Injection[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(24):3122-3126. |
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| 摘要: |
| 目的 比较电感耦合等离子质谱法（ICP-MS）、电感耦合等离子原子发射光谱法（ICP-AES）和高效液相色谱法（HPLC）测定复方氨基酸类注射液中铝元素含量的差异。方法 通过方法学验证和样品测定，对比分析3种方法的线性、重复性、准确度、定量限、检测限和样品测定结果。结果 ICP-MS、ICP-AES和HPLC 3种方法在5~200μg·L-1内相关系数均>0.999；重复性结果相对平均偏差RSD （n=6）分别为2.4%，5.5%和7.6%；加样回收率分别为103.2%，106.0%和105.7%；定量限分别为1.2，4.1，5.0μg·L-1；ICP-MS法和ICP-AES法的检出限分别为0.4，1.2μg·L-1；43批复方氨基酸类注射液样品的铝元素测定结果基本一致。结论 3种方法均可满足复方氨基酸类注射液中铝元素含量的测定要求，ICP-MS法简便、快速、准确。HPLC仪器成本较低，更易于实验室推广。 |
| 关键词: 电感耦合等离子质谱法 电感耦合等离子原子发射光谱法 高效液相色谱法 复方氨基酸类注射液 铝 |
| DOI：10.13748/j.cnki.issn1007-7693.2021.24.012 |
| 分类号:R917.101 |
| 基金项目:“重大新药创制”国家科技重大专项（2015ZX09303001002011） |
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| Comparison of Three Determination Methods of Aluminum in Compound Amino Acid Injection |
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KAN Weina, WANG Ji, CHEN Mo, WANG Quanyi, YANG Hongwei
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Liaoning Inspection, Examination & Certification Centre, Liaoning Institute for Drug Control, State Key Laboratory of Chemical Drug Quality Research and Evaluation, Shenyang 110036, China
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| Abstract: |
| OBJECTIVE To compare the difference in the determination of aluminum in Compound Amino Acid injection by ICP-MS, ICP-AES and HPLC. METHODS Compare the linearity, repeatability, accuracy, quantification limit, detection limit and sample determination results of the three methods by methodological verification and sample determination. RESULTS The linearity range of ICP-MS, ICP-AES and HPLC was 5-200 µg·L-1, the correlation coefficients were all greater than 0.999; the RSD(n=6) of repeatability were 2.4%, 5.5%, and 7.6%; the recovery rates were 103.2%, 106.0%, and 105.7%; the limits of quantification were 1.2, 4.1, 5.0 µg·L-1, respectively; the detection limits of ICP-MS and ICP-AES were 0.4, 1.2 µg·L-1. The contents of aluminum in 43 batches of Compound Amino Acid injection were basically the same. CONCLUSION The three methods can satisfy the determination requirements of aluminum in Compound Amino Acid injection. ICP-MS is simple, fast and accurate; HPLC has lower instrument costs and is easier to promote in the laboratory. |
| Key words: ICP-MS ICP-AES HPLC Compound Amino Acid injection aluminum |
