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

Heggie, Jean R.; Wu, Mark N.; Burns, Robbin B.; Ng, Carol S.; Fung, Henry C.; Knight, Gregory; Barnett, Michael J.; Spinelli, John J.; Embree, Leanne

doi:10.1016/s0378-4347(96)00520-8

Cited by 31 publications

(21 citation statements)

References 23 publications

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“…The sensitivity is 10 -25 times higher than those of the UV-HPLC methods. 15,16,19,25 Selectivity of the method Several drugs examined gave no fluorescent derivatives under the described conditions, even at a concentration of 5 µg ml -1 , i.e. heparin, diazepam, cyclophosphamide, 5-fluorouracil, melphalan, cytarabine, prednisolone, granisetron and morphine which are frequently coadministered with busulfan.…”

Section: Quantitative Analysis Of Busulfan In Human Serummentioning

confidence: 98%

High-Performance Liquid Chromatographic Quantification of Busulfan in Human Serum after Fluorescence Derivatization by 2-Naphthalenethiol

et al. 2000

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Section: Quantitative Analysis Of Busulfan In Human Serummentioning

confidence: 98%

High-Performance Liquid Chromatographic Quantification of Busulfan in Human Serum after Fluorescence Derivatization by 2-Naphthalenethiol

et al. 2000

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“…Analogous compounds such as 1,6-bis-(methanesulfonyloxy)hexane [20,21 ] [27] suitable as an IS are not available as commercial products. Our choice was BAD, a monofunctional alkylating compound, available as a crystalline and stable material, which is, in similar circumstances, routinely used as an IS for the determination of a bifunctional anticancer alkylating agent, dibromomannitol (DBM, myelobromol) [26].…”

Section: ]mentioning

confidence: 99%

High-performance liquid chromatographic determination of busulfan in plasma

2000

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KeyWordsColumn liquid chromatography Normal-phase chromatography Busulfan in plasma Derivatization with diethyldithiocarbamate SummaryBusulfan (Myleran; 1,4-bis-(methanesulfonyloxy) butane; BU) is a bifunctional alkylating agent used in clinical practice since 1959. It is currently included at high doses in conditioning regimens for bone marrow transplantation, usually in combination with cyclo-phosphamide. A high-performance liquid chromatographic method has been developed for the determination of BU in plasma. The basis of the assay is a derivatization with sodium diethyldithiocarbamate at 32 ~ C in the presence of 1-bromo-l-deoxy-3,6-anhydrogalactitol as internal standard. Analysis is performed on a cyano column with heptane-isopropanol-glacial acetic acid as mobile phase and UV detection at 280 nm. The calibration graph was linear in the concentration range 0.18 46.40 #M BU in plasma. The limit of detection was 0.1/tM. The precision and accuracy were between the limits required by good laboratory practice.

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“…Different analytical methods have been developed for busulfan measurement in plasma and other biological fluids, including GC and GC-MS [4][5][6][7], HPLC with UV detection [8][9][10], and with fluorescence detection [11,12] and LC-MS [13,14]. In the present study, we compared two published methods: (1) a rapid and accurate LC-MS assay with SIM mode, (2) a sensitive HPLC-FL assay using 2-naphthalenethiol derivatization for the busulfan quantitation.…”

Section: Introductionmentioning

confidence: 99%

Comparison of LC-MS Assay and HPLC Assay of Busulfan in Clinical Pharmacokinetics Studies

Lin¹,

Goodin²,

Strair³

et al. 2012

ISRN Analytical Chemistry

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Busulfan is used in preparative regimens for bone marrow transplantation and timely busulfan plasma concentration reporting is critical for subsequent dose adjustment. We compared two sensitive methods for pharmacokinetics studies including LC-MS assay and HPLC precolumn derivatization assay. Chromatographic separation was performed on a Gemini C18column. Liquid-liquid extraction with ethyl acetate was used for plasma sample preparation. Busulfan and internal standard ([2H8]-busulfan) were detected as ammonium adducts at m/z 264.2 and 272.2 for LC-MS assay. For HPLC assay, the extraction from plasma was derivatized with 2-naphathalenethiol using synthesized internal standard (1,6-(methanesulfonyloxy)octane). The Ex and Em wavelength was 255 nm and 370 nm. The limit of detection was 15.6 ng/mL and 7.8 ng/mL for HPLC and LC-MS assay and good linearity ranging from 31.25–1000 ng/mL for HPLC and 15.6-1000 ng/mL for LC-MS assay. The intra and interday assay precision were less than 9.2% and 12.0% for LC-MS and HPLC assay. The pharmacokinetic parameters were estimated using noncompartmental pharmacokinetic model with WinNonlin. Busulfan AUClast showed an average difference of 0.7% between the two methods. The LC-MS method is accurate, reproducible, and requires less specimen, sample preparation and analysis time over the HPLC assay, making busulfan monitoring faster and easier in clinical practice.

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

Cited by 31 publications

References 23 publications

High-Performance Liquid Chromatographic Quantification of Busulfan in Human Serum after Fluorescence Derivatization by 2-Naphthalenethiol

High-Performance Liquid Chromatographic Quantification of Busulfan in Human Serum after Fluorescence Derivatization by 2-Naphthalenethiol

High-performance liquid chromatographic determination of busulfan in plasma

Comparison of LC-MS Assay and HPLC Assay of Busulfan in Clinical Pharmacokinetics Studies

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