Chinese Journal of Pharmacovigilance ›› 2025, Vol. 22 ›› Issue (4): 386-390.
DOI: 10.19803/j.1672-8629.20240850

Previous Articles     Next Articles

Uncertainty Evaluation for the Determination of Tacrolimus Content in Human Whole Blood by UPLC-MS/MS Method

WANG Jiaqing1, WANG Qi2,△, LIU Tongtong3, ZHANG Dongjie3, NING Xiao*   

  1. 1Clinical Trial Center, Beijing Tiantan Hospital, Capital Medical University, Beijing 100050, China;
    2Institute for Control of Chinese Traditional Medicine and EthnicMedicine, National Institutes for Food and Drug Control, Beijing 100050, China;
    3Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing 100050, China;
    4Institute for Food and Cosmetics Testing, National Institutes for Food and Drug Control, Beijing 100050, China
  • Received:2024-11-01 Published:2025-04-17

Abstract: Objective To evaluate the uncertainty of human whole blood tacrolimus (TAC) by ultra-performance liquid chromatography-mass spectrometry coupled with immunosuppressant kits. Methods The source of uncertainty in the concentration of TAC in human whole blood was analyzed and synthesized by UPLC-MS/MS. Results The extended uncertainty of a low concentration (3.54 mg·L-1) and a high concentration (14.89 mg·L-1) of TAC in human whole blood was 0.177 8 mg·L-1 and 0.7 mg·L-1, respectively (P=95%, k=2). Conclusion In this study, we have explored the establishment of a systematic evaluation standard for applications of uncertainty evaluation methods to immunosuppre-ssant kits,which can effectively identify the key error sources in the measurement process and provide a reference for the improvement and optimization of the kits.

Key words: Tacrolimus, UPLC-MS/MS, Content Determination, Uncertainty Evaluation, Whole Blood

CLC Number: