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电感耦合等离子质谱法测定碳酸镧原料药中24种元素杂质含量

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  • 四川省药品检验研究院(四川省医疗器械检测中心),成都 611731
第一作者 Tel:(028)87877185; E-mail:659717916@qq.com
*Tel:(028)64020264; E-mail:623828337@qq.com

收稿日期: 2020-10-13

  网络出版日期: 2024-06-24

Determination of 24 element impurities in lanthanum carbonate API by inductively coupled plasma mass spectrometry

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  • Sichuan Institute for Drug Control(Sichuan Testing Center for Medical Devices), Chengdu 611731, China

Received date: 2020-10-13

  Online published: 2024-06-24

摘要

目的:建立电感耦合等离子体质谱(ICP-MS)法测定碳酸镧原料药中24种具有潜在风险的元素杂质锡、锑、钡、铱、铂、铊、铅、钒、铬、钴、镍、铜、砷、钼、钌、镉、钯、锂、硒、锇、银、铑、金、汞的含量。方法:采用高浓度酸超声溶解,超纯水稀释方式制样,以高基体进样方式对碳酸镧原料药元素杂质进行含量分析,运用砬撞模式消除双电荷干扰,通过在线内标方式消除基质效应。结果:24种元素杂质的检测下限为0~0.76 ng·mL-1,方法检测下限为0~0.76 μg·g-1,加样回收率为81.1%~118.8%。3批样品中24种元素杂质含量均未超过限度。结论:本方法准确,灵敏度高,简便可行,可以为碳酸镧原料药元素杂质控制提供有力技术保障。

本文引用格式

任锟, 郭燕燕, 王晓兰, 张晗, 江燕 . 电感耦合等离子质谱法测定碳酸镧原料药中24种元素杂质含量[J]. 药物分析杂志, 2021 , 41(11) : 1968 -1978 . DOI: 10.16155/j.0254-1793.2021.11.15

Abstract

Objective: To establish an ICP-MS method for the determination of 24 types of element impurities with potential risks in the crude drug of lanthanum carbonate, such as Sn, Sb, Ba, Ir, Pt, Tl, Pb, V, Cr, Co, Ni, Cu, As, Mo, Ru, Cd, Pd, Li, Se, Os, Ag, Rh, Au and Hg. Methods: High concentration acid ultrasonic dissolution and ultrapure water dilution were adopted to prepare the samples, collision mode was used to eliminate double charge interference, and the contents of element impurities in the crude drug of lanthanum carbonate were analyzed by high matrix injection, and the matrix effect was eliminated by online internal standard. Results: The lower limits of detection of the 24 impurity elements were 0-0.76 ng·mL-1, the lower limits of detection of the method were 0~0.76 μg·g-1, and the spiked recoveries were in the range of 81.1%-118.8%. The content of 24 kinds of impurity elements in 3 batches of samples did not exceed the limits. Conclusion: This method is accurate, sensitive, simple and feasible, and can provide strong technical support for the control of lanthanum carbonate impurities.

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