ArticleDaru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences2026
A cost-efficient internal standard approach for busulfan quantification: MS-based investigation of adduct formation in therapeutic drug monitoring.
Article in Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundBusulfan plays a central role in conditioning regimens for hematopoietic stem cell transplantation (HSCT). However, its narrow therapeutic index and substantial interpatient pharmacokinetic variability necessitate precise therapeutic drug monitoring (TDM). Because busulfan is highly lipophilic, many LC-MS/MS assays rely on costly stable-isotope-labeled internal standards (e.g., busulfan-d8), which limits their routine application in resource-constrained settings.
methodsThis study aimed to synthesize cost-effective structural analogs of busulfan and evaluate their chromatographic behavior and cation-adduct formation as potential alternative internal standards. Four dimethanesulfonate analogs were synthesized from symmetrical n-diols (n = 3-6) under alkaline conditions (47-55% yields). The synthesized analogs were evaluated as candidate internal standards by investigating their cation-adduct formation behavior using liquid chromatography-electrospray ionization-quadrupole time-of-flight high-resolution mass spectrometry (LC-ESI-qTOF-HRMS).
resultsEach analog formed distinct cation adducts (H
conclusionThese findings provide mechanistic and analytical evidence to support the selection of a cost-efficient internal standard for busulfan quantification. However, full bioanalytical validation in biological matrices will be required before routine clinical implementation.
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