Safety Monitoring

Determination of multiple elements in complex injections by inductively coupled plasma-mass spectrometry*

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  • 1. Guangdong Jiabo Pharmaceutical Co., Ltd., Qingyuan 511517, China;
    2. Guangdong Engineering Center of Intravenous Lipid Emulsion, Qingyuan 511517, China

Received date: 2022-02-15

  Online published: 2024-06-24

Abstract

Objective: To establish an inductively coupled plasma-mass spectrometry method for the determination of 24 elements in injectable emulsion. Method: The injectable emulsion was first filtered and then diluted with water for injection or diluted nitric acid (2%). The test solution and internal standard solution (Sc or Ge、In、Re included) were injected into the ICP-MS at the same time for determination of multiple elements. Octopole reaction system (ORS) was applied to eliminate the interference of polyatomic ions dramatically along with internal standard method. Results: Linearity for 24 elements was good (r≥0.999), and RSD for repeatability, precision and stability of the solution was less than 5%,15% and 10% respectively. Limit of quantitation, limit of detection and robustness were validated with good results. The average recovery of each element was 75.6%-117.1% (RSD was 0.10%-8.3%). The content of 24 elements in both in-house samples and commercially available products were far less than the limit. Conclusion: This method is simple to operate. It can be used in the determination of multiple elements in injectable emulsion with good reproducibility and high sensitivity. It can also be applied to other complex injections made of similar matrix and provide better technical support for the quality control of complex injection.

Cite this article

XIE Chun-yan, WU Si-yun, ZHANG Hong-jian, TIAN Liang, ZENG Shao-qun, YUE Feng . Determination of multiple elements in complex injections by inductively coupled plasma-mass spectrometry*[J]. Chinese Journal of Pharmaceutical Analysis, 2023 , 43(2) : 289 -296 . DOI: 10.16155/j.0254-1793.2023.02.12

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