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A Simple and Accurate Liquid Chromatography-Tandem Mass Spectrometry Method for Therapeutic Drug Monitoring of Busulfan in Plasma

A Simple and Accurate Liquid Chromatography-Tandem Mass Spectrometry Method for Therapeutic Drug Monitoring of Busulfan in Plasma

Eun Jin Lee, Nuri Park, Sang Hee Lee, Woochang Lee, Hyun Soo Kim, Sail Chun, Won-Ki Min

Ann Clin Lab Sci. 2019 Mar;49(2):212-217.

PMID: 31028066

Abstract:

Objective:
Busulfan, frequently used as a conditioning regimen for hematopoietic stem cell transplantation, has a narrow therapeutic range and wide intra-and interpatient variabilities. Therefore, therapeutic drug monitoring of busulfan is necessary to ensure that the drug concentrations of patients are within a targeted therapeutic range. In this study, we developed a simple and accurate method for measuring busulfan concentrations using liquid chromatography tandem mass spectrometry (LC-MS/MS).
Methods:
Separation and detection of busulfan was performed using T3 column equipped with LC-MS/MS. Busulfan was isolated from 50 μL human plasma after mixing with busulfan-2H8 (internal standard) solution, calibrator, and quality-control material. The sample was eluted and gradated with a mobile phase composed of ammonium acetate, formic acid, and water or methanol. The busulfan concentration was quantified using a six-point standard curve. Busulfan and busulfan-2H8 were detected in positive-ion multiple-reaction-monitoring mode. According to the Clinical and Laboratory Standards Institute guideline, we verified the precision, linearity, limit of detection (LOD), limit of quantification (LOQ), and carryover.
Results:
Busulfan and busulfan-2H8 were detected at m/z 264.1>151.1 and 272.2>159.1. The total run time was 3 min. Both intra-and inter-assay coefficients of variation were <3%. The calibration curve was linear at 25-5,000 ng/mL. The LOD and LOQ were 2.5 ng/mL and 25 ng/mL, respectively. The recoveries ranged from 92.0-104.8% and the carryover was-0.02%.
Conclusions:
Our method for busulfan reduces total run time and has excellent analytical performance. It will be a useful method for therapeutic drug monitoring of busulfan in clinical laboratories.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP31961021-B	O-Methyl-O′-succinylpolyethylene glycol 5′000		31961-02-1	Price

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