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Sensitive, wide‐range and high‐throughput quantification of cyclosporine in whole blood using ultra‐performance liquid chromatography coupled to tandem mass spectrometry and comparison with an antibody‐conjugated magnetic immunoassay
Author(s) -
Watanabe Takuma,
Tanaka Ryota,
Ono Hiroyuki,
Suzuki Yosuke,
Tatsuta Ryosuke,
Itoh Hiroki
Publication year - 2021
Publication title -
biomedical chromatography
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.4
H-Index - 65
eISSN - 1099-0801
pISSN - 0269-3879
DOI - 10.1002/bmc.5128
Subject(s) - chromatography , chemistry , high performance liquid chromatography , tandem mass spectrometry , mass spectrometry , whole blood , analyte , calibration curve , solid phase extraction , liquid chromatography–mass spectrometry , immunoassay , selected reaction monitoring , bioanalysis , therapeutic drug monitoring , detection limit , extraction (chemistry) , pharmacokinetics , antibody , pharmacology , medicine , immunology , biology
Because either trough or peak concentration at 2 h after administration is measured in routine therapeutic drug monitoring for cyclosporine A (CyA), a quantification method with a wide‐range calibration curve capable of simultaneously measuring both concentrations is required. We developed a sensitive, wide‐range and high‐throughput quantification method for CyA in whole blood using ultra‐performance liquid chromatography–tandem mass spectrometry (UPLC–MS/MS), and compared patients’ blood CyA levels measured by UPLC–MS/MS and antibody‐conjugated magnetic immunoassay (ACMIA). Whole blood samples were prepared by solid‐phase extraction using Oasis HLB μElution plate. The UPLC–MS/MS assay showed excellent linearity over a wide calibration range of 5–2500 ng/mL. Within‐batch accuracy and precision as well as batch‐to‐batch accuracy and precision fulfilled the criteria of US Food and Drug Administration guidelines. The blood CyA concentrations measured by the UPLC–MS/MS assay correlated strongly with those measured by ACMIA. A Bland–Altman plot showed a fixed error between CyA concentrations measured by the two methods, and the concentrations measured by the UPLC–MS/MS method were consistently lower than those measured by ACMIA. We have succeeded to develop a sensitive, wide‐range and high‐throughput quantification method for CyA in whole blood using UPLC–MS/MS.