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中国药物评价 ›› 2021, Vol. 38 ›› Issue (3): 202-205.

• 评价技术与方法 • 上一篇    下一篇

HPLC法测定盐酸利多卡因注射液含量的不确定度评定

张志超1, 袁晓转1, 韩慧丽2   

  1. 1. 洛阳市食品药品检验所, 河南 洛阳 471000;
    2. 河南科技大学第一附属医院, 河南 洛阳 471000
  • 收稿日期:2020-10-28 修回日期:2021-01-26 出版日期:2021-06-28 发布日期:2021-06-28

Uncertainty Evaluationon of the Content Determination of Lidocaine#br#      Hydrochloride Injection by HPLC

ZHANG Zhi-chao1, YUAN Xiao-zhuan1, HAN Hui-li2   

  1. 1. Luoyang Institute for Food and Drug Control, Henan Luoyang 471000, China;
    2. The First Affiliated Hospital of Henan University of Science and Technology, Henan Luoyang 471000, China
  • Received:2020-10-28 Revised:2021-01-26 Online:2021-06-28 Published:2021-06-28
  • Contact: Zhang zhichao E-mail:18103796875@qq.com

摘要: 目的:采用高效液相色谱(HPLC)法测定盐酸利多卡因注射液中盐酸利多卡因的含量,对其不确定度进行评定。方法: 根据CNAS-GL006-2019《化学分析中不确定度的评估指南》、JJF1059.1-2012《测量不确定度评定与表示》要求,建立不确定度评估的数学模型,对其各主要分量进行分析,得出合成不确定度以及扩展不确定度,最终进行含量测定结果不确定度评定。结果: HPLC法测定盐酸利多卡因含量合成不确定度为0.243%,扩展不确定度为0.49%,盐酸利多卡因含量测定结果表示为(101.3±0.49)%,k=2。结论: 移液管移取样品的准确性是试验中不确定度的主要来源。
 

关键词: font-size:13.3333px, ">盐酸利多卡因注射液;高效液相色谱;含量测定;测量不确定度评定

Abstract: Objective: To evaluate the uncertainty in content determination of Lidocaine Hydrochloride Injection by HPLC. Methods: According to CNAS-GL006-2019 and JJF1059.1-2012, establish a mathematical model of uncertainty evaluation, analyze and calculate the main components of uncertainty, and obtain the combined uncertainty and the expanded uncertainty, which are finally measured uncertainty evaluation of results. Results: The conbined uncertainty in the determination is 0.243%, and the expanded uncertainty is 0.49%. The content of lidocaine hydrochloride is (101.3±0.49)%, k=2.Conclusion: The uncertainty of the method is mainly caused by the accuracy of pipetting samples.
 

Key words: font-size:13.3333px, ">Lidocaine hydrochloride injection;High Performance Liquid Chromatography(HPLC);Content determination;Uncertainty evaluation

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