超高效液相色谱质谱联用法测定大鼠血浆中氨溴索含量与不确定度评定

doi:10.19803/j.1672-8629.20240851

中国药物警戒 ›› 2025, Vol. 22 ›› Issue (4): 381-385.
DOI: 10.19803/j.1672-8629.20240851

• 液相色谱质谱联用法在药物临床评价中的应用研究专栏 • 上一篇下一篇

超高效液相色谱质谱联用法测定大鼠血浆中氨溴索含量与不确定度评定

金绍明, 宁霄^*

中国食品药品检定研究院食品化妆品检定所,国家市场监督管理总局食品质量与安全重点实验室,北京 100050

收稿日期:2024-11-01 发布日期:2025-04-17
通讯作者: ^*宁霄,女,博士,主任药师,分析化学研究。E-mail: nx200730079@163.com
作者简介:金绍明,女,博士,副研究员,食品药品分析。
基金资助:
国家重点研发计划（2021YFC2401100）

Uncertainty Evaluation for Determination of Ambroxol in Rat Plasma by UPLC-MS/MS Method

JIN Shaoming, NING Xiao^*

Institute for Food and Cosmetics Testing, National Institutes for Food and Drug Control;Laboratory of Food Quality and Safety, State Administration for Market Regulation, Beijing 100050, China

Received:2024-11-01 Published:2025-04-17

摘要/Abstract

摘要： 目的建立超高效液相色谱质谱联用（UPLC-MS/MS）法测定大鼠血浆氨溴索的方法,并分析该方法的不确定度。方法分析测定方法建立过程中不确定度的来源并进行合成。结果大鼠血浆中氨溴索在低浓度（20 ng·mL^-1）和高浓度（400 ng·mL^-1）测定时的扩展不确定度分别为1.25、20.82 ng·mL^-1（P=95％,k=2）。结论 UPLC-MS/MS法测定大鼠血浆中氨溴索浓度的不确定度,在低浓度时主要由标准曲线拟合、溶液配制及重复性引入,高浓度时主要来源于血浆回收率、基质效应。

关键词: 氨溴索, 超高效液相色谱质谱联用, 含量测定, 不确定度, 大鼠, 血浆

Abstract: Objective To develop a method for the determination of ambroxol in rat plasma using ultra-high performance liquid chromatography-mass spectrometry (UPLC-MS/MS), and to analyze the uncertainty associated with this method. Methods The sources of uncertainty in the process of establishing the UPLC-MS/MS method for determining ambroxol in rat plasma were analyzed and synthesized. Results The extended uncertainties at a low concentration (20 ng·mL^-1) and at a high concentration (400 ng·mL^-1) of ambroxol in rat plasma were 1.25 ng·mL^-1 and 20.82 ng·mL^-1, respectively (P=95%, k=2). Conclusion The uncertainty that arises from the determination of concentrations of ambroxol in rat plasma using the UPLC-MS/MS method is primarily introduced by standard curve fitting, solution preparation, and repeatability at low concentrations, and by the plasma recovery rate and matrix effects at high concentrations.

Key words: Ambroxol, UPLC-MS/MS, Content Determination, Uncertainty, Rats, Plasma

中图分类号:

R917

金绍明, 宁霄. 超高效液相色谱质谱联用法测定大鼠血浆中氨溴索含量与不确定度评定[J]. 中国药物警戒, 2025, 22(4): 381-385.

JIN Shaoming, NING Xiao. Uncertainty Evaluation for Determination of Ambroxol in Rat Plasma by UPLC-MS/MS Method[J]. Chinese Journal of Pharmacovigilance, 2025, 22(4): 381-385.

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超高效液相色谱质谱联用法测定大鼠血浆中氨溴索含量与不确定度评定

Uncertainty Evaluation for Determination of Ambroxol in Rat Plasma by UPLC-MS/MS Method

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