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

doi:10.19803/j.1672-8629.20240851

Abstract

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

CLC Number:

R917

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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URL: https://zgywjj.magtechjournal.com/EN/10.19803/j.1672-8629.20240851

https://zgywjj.magtechjournal.com/EN/Y2025/V22/I4/381

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