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《化学分析计量》 2021年第06期
DOI:10.3969/j.issn.1008-6145.2021.06.012
电感耦合等离子体质谱法测定阿莫西林原料药中的7种杂质元素
张春华,陈亮,陈春桃,韩必恺,李子宜,吴惠勤,黄晓兰
广东省科学院测试分析研究所(中国广州分析测试中心),广东省化学危害应急检测技术重点实验室,广东省中药质量安全工程技术研究中心,广州 510070 
Determination of seven kinds of elemental impurities in amoxicillin active pharmaceutical ingredient by using inductively coupled plasma mass spectrometry
Zhang Chunhua, Chen Liang, Chen Chuntao, Han Bikai, Li Ziyi, Wu Huiqin, Huang Xiaolan
Institute of Analysis, Guangdong Academy of Sciences(China National Analytical Center, Guangzhou), Guangdong Provincial Engineering Research Center for Quality and Safety of Traditional Chinese Medicine, Guangdong Provincial Key Laboratory of Emergency Test for Dangerous Chemicals, Guangzhou 510070, China 
摘要:建立电感耦合等离子体质谱(ICP-MS)法测定阿莫西林原料药中钒、钴、镍、砷、镉、铅、汞7种杂质元素含量的方法。样品经2%硝酸直接溶解,以72Ge、115In、185Re为内标,采用ICP-MS法测定溶液中杂质元素含量。7种元素在各自的检测质量浓度范围内线性关系良好(r>0.999)。低、中、高3种浓度水平平均加标回收率为86.1%~130.9%,重复性精密度为1.5%~4.5%(n=6),中间精密度为1.3%~6.3%(n=12),方法的定量限为0.1 mg/kg,满足方法学验证的要求。该方法操作简便、快速,灵敏度与准确度高,适合阿莫西林原料药中的7种杂质元素含量的测定,可为原料药中元素杂质分析方法的建立与评价提供参考。 
Abstract:A method for the determination of vanadium(V), cobalt(Co), nickel(Ni), arsenic(As), cadmium(Cd), lead(Pb) and mercury(Hg) in amoxicillin active pharmaceutical ingredient(API) by using inductively coupled plasma mass spectrometry (ICP-MS) was developed. The amoxicillin API was pretreated by dissolving and diluting with 2% nitric acid, then the seven target elemental impurities and internal standard elements (72Ge, 115In, 185Re) were detected by ICP-MS. The linear relationships of the seven elements were good within their respective detection mass concentration ranges(r>0.999). The average recoveries for the seven elemental impurities at three spiked levels (low, medium and high concentration) were in the range of 86.1%-130.9%, the repeatability relative standard deviations were 1.5%-4.5%(n=6) and the intermediate precision relative standard deviations were 1.3%-6.3%(n=12). The limits of quantitation for the seven elements were 0.1 mg/kg. The method is easy to handle, rapid, sensitive, meets the method validation requirements, and is suitable for the determination of the seven elemental impurities in amoxicillin APIs. It also can supply a reference for the determination of the elemental impurities in the APIs. 
关键词:电感耦合等离子体质谱法;阿莫西林;原料药;元素杂质 
Keywords:inductively coupled plasma mass spectrometry(ICP-MS); amoxicillin; active pharmaceutical ingredient; elemental impurities 
本文引用格式:
张春华,陈亮,陈春桃,等.电感耦合等离子体质谱法测定阿莫西林原料药中的7种杂质元素[J].化学分析计量,2021,30(6):52.
Zhang Chunhua,Chen Liang,Chen Chuntao,et al. Determination of seven kinds of elemental impurities in amoxicillin active pharmaceutical ingredient by using inductively coupled plasma mass spectrometry[J]. Chemical Analysis and Meterage,2021,30(6):52. 

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