Simultaneous Determination of Total and Unbound Amphotericin B by LC-MS/MS: Application to Protein Binding Analysis.

Λεπτομέρειες βιβλιογραφικής εγγραφής
Τίτλος:	Simultaneous Determination of Total and Unbound Amphotericin B by LC-MS/MS: Application to Protein Binding Analysis.
Συγγραφείς:	Kan M; Pharmacy Department, Zhongda Hospital, Southeast University, Nanjing, Jiangsu, China., Yang F; Department of Pharmacy, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Jinan, Shandong, China., Zhu ML; Department of Pharmacy, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China., Nie AQ; Department of Clinical Pharmacy, School of Pharmaceutical Sciences, Shandong University, Jinan, China., Xie J; Pharmacy Department, Zhongda Hospital, Southeast University, Nanjing, Jiangsu, China., Wang SJ; Department of Pharmacy, The Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China.
Πηγή:	Biomedical chromatography : BMC [Biomed Chromatogr] 2026 Oct; Vol. 40 (10), pp. e70600.
Τύπος έκδοσης:	Journal Article
Γλώσσα:	English
Στοιχεία περιοδικού:	Publisher: Wiley Country of Publication: England NLM ID: 8610241 Publication Model: Print Cited Medium: Internet ISSN: 1099-0801 (Electronic) Linking ISSN: 02693879 NLM ISO Abbreviation: Biomed Chromatogr Subsets: MEDLINE
Imprint Name(s):	Publication: 1990- : Chichester : Wiley Original Publication: London : Heyden & Son, c1986-1990
Ιατρικοί όροι (MeSH):	Amphotericin B/blood , Amphotericin B/metabolism , Amphotericin B/chemistry , Amphotericin B/pharmacokinetics , Tandem Mass Spectrometry/methods , Liquid Chromatography-Mass Spectrometry/methods , Antifungal Agents/blood , Antifungal Agents/metabolism, Humans ; Protein Binding ; Reproducibility of Results ; Linear Models ; Limit of Detection
Περίληψη:	Amphotericin B (AmB), a first-line antifungal agent, is highly protein-bound, and its efficacy and toxicity are primarily determined by the unbound fraction. However, current therapeutic drug monitoring mainly relies on total plasma concentrations, and clinical data on unbound AmB remain limited. In this study, a rapid and sensitive LC-MS/MS method was developed and validated in accordance with ICH M10 guidelines for the simultaneous quantification of total and unbound AmB concentrations. The method was successfully applied to 52 clinical samples from 26 patients. Correlation analysis combined with locally estimated scatterplot smoothing demonstrated that the protein binding rate (PBR) of AmB was associated with multiple biochemical parameters as well as total drug concentration. Subgroup analyses further revealed significant differences in PBR stratified by total concentration, albumin levels, and eGFR. The method requires only a small plasma volume and shows good applicability in clinical samples, providing a practical tool for investigating unbound pharmacokinetics and supporting individualized therapeutic drug monitoring, particularly in patients with altered protein-binding capacity. (© 2026 John Wiley & Sons Ltd.)
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Grant Information:	A202105 Jiangsu Provincial Pharmaceutical Society - Aosaikang Hospital Pharmacy Research Fund; 2021YX008 Nanjing Pharmaceutical Society - Changzhousiyao Hospital Pharmaceutical Research Fund
Contributed Indexing:	Keywords: LC–MS/MS; amphotericin B; fungal infections; protein binding rate; unbound
Substance Nomenclature:	7XU7A7DROE (Amphotericin B) 0 (Antifungal Agents)
Entry Date(s):	Date Created: 20260817 Date Completed: 20260817 Latest Revision: 20260819
Update Code:	20260819
PubMed Central ID:	PMC13481132
DOI:	10.1002/bmc.70600
PMID:	42608032
Βάση Δεδομένων:	MEDLINE

Περιγραφή
ISSN:	1099-0801
DOI:	10.1002/bmc.70600