Uncertainty evaluation on the determination of norvancomycin in human cerebrospinal fluid by UPLC-MS/MS

doi:10.19803/j.1672-8629.20230541

Abstract

Abstract: Objective To evaluate the uncertainty in norvancomycin (NVCM) determination in human cerebrospinal by UPLC-MS/MS. Methods The whole process during the NVCM determination was analyzed and the uncertainty sources were established, then the combined and expanded uncertainty were also evaluated. Results The expanded uncertainty with low (3 mg·L^-1) and high (300 mg·L^-1) levels of NVCM (P=95%, k=2) were 1.18 mg·L^-1 and 70.97 mg·L^-1, respectively. Conclusion The uncertainty in NVCM determination in human cerebrospinal by UPLC-MS/MS was mainly caused by curve fitting, repeatability and recovery for low concentrations and repeatability, matrix effect and recovery for high concentrations. The method for determining the content of NVCM in cerebrospinal fluid established by our research institute provides an effective regulatory means for the safety and effectiveness of the drug’s use.

Key words: NVCM, human cerebrospinal fluid, UPLC-MS/MS, UNcertainty evaluation, content, safety

CLC Number:

R917

WANG Jiaqing, WANG Qi, ZHANG Dongjie, MEI Shenghui, NING Xiao. Uncertainty evaluation on the determination of norvancomycin in human cerebrospinal fluid by UPLC-MS/MS[J]. Chinese Journal of Pharmacovigilance, 2023, 20(12): 1346-1350.

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