中国药物警戒 ›› 2021, Vol. 18 ›› Issue (7): 611-613.
DOI: 10.19803/j.1672-8629.2021.07.03

• 化学药品一致性评价专栏 • 上一篇    下一篇

电感耦合等离子体质谱法测定注射用泮托拉唑钠中硅的含量

段希英1, 王董云1, 徐佳1, 仇雅静1,*, 许明哲2#   

  1. 1泰州市药品检验院,江苏 泰州225300;
    2中国食品药品检定研究院,北京 102629
  • 收稿日期:2021-03-24 出版日期:2021-07-15 发布日期:2021-07-23
  • 通讯作者: *仇雅静,女,本科,主任中药师,药品质量控制和标准研究。E-mail：1908368215@qq.com;#为共同通信作者。
  • 作者简介:段希英,女,硕士,主管药师,药物分析。
  • 基金资助:
    重大新药创制国家科技重大专项2017年度（2017zx09101001）

Determination of Silicon in Pantoprazole Sodium for Injection by ICP-MS

DUAN Xiying1, WANG Dongyun1, XU Jia1, QIU Yajing1,*, XU Mingzhe2#   

  1. 1Taizhou Institute for Drug Control, Taizhou Jiangsu 225300, China;
    2National Institutes for Food and Drug Control, Beijing 102629, China
  • Received:2021-03-24 Online:2021-07-15 Published:2021-07-23

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摘要： 目的 建立注射用泮托拉唑钠中硅含量的测定方法。方法 采用电感耦合等离子体质谱法（ICP-MS）,以45钪（45Sc）作为28硅（28Si）的内标,测定注射用泮托拉唑钠中硅的含量。结果 硅在100~5000 ng/mL浓度范围内呈良好的线性关系（r=0.999 9）,精密度试验的相对标准偏差（RSD）为0.7%,重复性试验的RSD为1.0%,中间精密度的RSD为1.1%,低、中、高3个浓度的平均加样回收率为102.3%（n=9）。结论 该方法准确、灵敏,适用于注射用泮托拉唑钠中硅含量的测定。

关键词: 泮托拉唑钠, 电感耦合等离子体质谱法, 硅, 测定

Abstract: Objective To establish a method for the determination of silicon in pantoprazole sodium for injection. Methods Inductively coupled plasma mass spectrometry (ICP-MS) was used to determine the contents of silicon, while 45Sc was used as the internal standard of 28Si. Results The linear ranges of Si was 100-5 000 ng/mL. The r value was 0.999 9. The RSD of precision was 0.7%, compared to 1.0% for the repeatability test, and 1.1% for intermediate precision. The average recovery rate of low, medium and high concentrations was 102.3% (n=9). Conclusion This method is accurate and sensitive, which can be used for determination of Si in pantoprazole sodium for injection.

Key words: pantoprazole sodium, inductively coupled plasma mass spectrometry, silicon, assay

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