PMID: 9188834May 9, 1997Paper

Validation of a high-performance liquid chromatographic assay method for pharmacokinetic evaluation of busulfan

Journal of Chromatography. B, Biomedical Sciences and Applications
J R HeggieL Embree

Abstract

The development and validation of a high-performance liquid chromatographic (HPLC) assay for determination of busulfan concentrations in human plasma for pharmacokinetic studies is described. Plasma samples containing busulfan and 1,6-bis(methanesulfonyloxy)hexane, and internal standard, were prepared by derivatization with sodium diethyldithiocarbamate (DDTC) followed by addition of methanol and extraction with ethyl acetate. The extract was dried under nitrogen and the samples reconstituted with 100 microl of methanol prior to HPLC determination. Chromatography was accomplished using a Waters NovaPak octadecylsilyl (ODS) (150 x 3.9 mm I.D.) analytical column, NovaPak ODS guard column, and mobile phase of methanol-water (80:20, v/v) at a flow-rate of 0.8 ml/min with UV detection at 251 nm. The limit of detection was 0.0200 microg/ml (signal-to-noise ratio of 6) with a limit of quantitation (LOQ) of 0.0600 microg/ml for busulfan in plasma. Calibration curves were linear from 0.0600 to 3.00 microg/ml in plasma (500 microl) using a 1/y weighting scheme. Precision of the assay, as represented by C.V. of the observed peak area ratio values, ranged from 4.41 to 13.5% (13.5% at LOQ). No day-to-day variability was observed in predicte...Continue Reading

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Citations

Jul 20, 2000·Journal of Chromatography. B, Biomedical Sciences and Applications·N BleyzacG Aulagner
Nov 17, 2001·Journal of Chromatography. B, Biomedical Sciences and Applications·M H QuerninE J Aigrain
Feb 23, 1999·Journal of Chromatography. B, Biomedical Sciences and Applications·M H QuerninE Jacqz-Aigrain
Oct 4, 2015·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Michael PhilippeSylvain Goutelle
Feb 2, 2006·Clinica Chimica Acta; International Journal of Clinical Chemistry·Makiko KusamaTatsuji Iga
Jan 25, 2008·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Michelle GeddesJames A Russell
Jul 31, 2012·Biology of Blood and Marrow Transplantation : Journal of the American Society for Blood and Marrow Transplantation·Andrew DalyJames Russell
Sep 22, 2005·Therapeutic Drug Monitoring·M D KelloggN Rifai
May 15, 2015·Therapeutic Drug Monitoring·Darlington DansoLoralie J Langman
May 6, 2011·Therapeutic Drug Monitoring·JoEtta M JuenkeKamisha L Johnson-Davis
Jan 31, 2002·Journal of Chromatography. B, Biomedical Sciences and Applications·A PaciP Prognon
Sep 1, 2021·Clinical Pharmacology and Therapeutics·Vanessa BaierLars Kuepfer

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