| 朱婧,宿亮,朱跃芳,左瑾蓉,赵静芝,王玲兰.电感耦合等离子体质谱法测定碳酸锂原料药中6种元素杂质[J].中国药事,2023,(4):414-419 |
| 电感耦合等离子体质谱法测定碳酸锂原料药中6种元素杂质 |
| Determination of Six Kinds of Elemental Impurities in Lithium Carbonate API by Using Inductively Coupled Plasma Mass Spectrometry |
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| DOI：10.16153/j.1002-7777.2023.04.007 |
| 中文关键词: 电感耦合等离子体质谱 碳酸锂 抗躁狂药 元素杂质 质量控制 |
| 英文关键词: inductively coupled plasma mass spectrometer lithium carbonate antimanic drugs elemental impurities quality control |
| 基金项目:湖南省自然科学基金资助项目(编号 2017JJ2123) |
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| 中文摘要: |
| 目的：建立电感耦合等离子体质谱法(ICP-MS)测定碳酸锂原料药中汞、铅、镉、钴、镍、钒 6种元素杂质含量以更好地控制药品质量。方法：样品经1%硝酸溶液直接溶解，以115In、209Bi为内标，采用ICP-MS测定碳酸锂中元素杂质含量。结果：6种元素在各自浓度范围内线性关系良好(r＞0.990)， 最大检测限和定量限分别为0.40 mg·kg-1、1.40 mg·kg-1。平均加标回收率为92.16%~ 112.87%，重复性 RSD为1.28%~6.63%(n=6)。结论：本方法前处理简单、检出限低、准确度高、精密度好，可用于碳酸锂中元素杂质研究和控制。 |
| 英文摘要: |
| Objective: To establish an inductively coupled plasma mass spectrometry (ICP-MS) method for the determination of mercury (Hg), lead (Pb), cadmium (Cd), cobalt (Co), nickel (Ni) and vanadium (V) in lithium carbonate API to better control the quality of drugs. Methods: The sample was directly solubilized in 1% nitric acid solution and the elemental impurities were determined by ICP-MS with 115In and 209Bi as internal standards. Results: The six elements showed good linear correlations within the respective concentration ranges (r＞0.990) with a maximum detection limit of 0.40 mg·kg-1 and a maximum quantitation limit of 1.40 mg·kg-1 respectively. The average spiked recoveries for six elemental impurities were in the range of 92.16%-112.87%. The repeatability relative standard deviations were 1.28%-6.63% (n=6). Conclusion: The method has simple pretreatment, low detection limit, high accuracy and good precision, and can be used for the study and control of elemental impurities in lithium carbonate. |
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