Journal
JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES
Volume 831, Issue 1-2, Pages 169-175Publisher
ELSEVIER
DOI: 10.1016/j.jchromb.2005.11.044
Keywords
plasma; laptinib (GW572016); liquid chromatography; electrospray tandem mass spectrometry (LC-ESI-MS/MS)
Funding
- NCI NIH HHS [P01 CA 23099, CA 21765, R21 CA 114937] Funding Source: Medline
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A sensitive method for the determination of lapatinib (GW572016) in human plasma was developed using high-performance liquid chromatographic separation with tandem mass spectrometric detection. Plasma samples (100 mu L) were prepared using solid phase extraction (SPE) columns, and 6.0 mu L of the reconstituted eluate was injected onto a Phenomenex (R) CuroSil-PFP 3 mu analytical column (50 mm x 2.0 mm) with an isocratic mobile phase. Analytes were detected with a PE SCIEX API-365 LC-MS/MS system at unit (Q1) and low (Q3) resolution in positive multiple reaction monitoring mode (m/z 581 (precursor ion) to m/z 364 (product ion) for lapatinib). The mean recovery for lapatinib was 75% with a lower limit of quantification of 15 ng/mL (S/N = 11.3, CV <= 14%). This method was validated over a linear range of 100-10,000 ng/mL, and results from a 5-day validation study demonstrated good within-day and between-day precision and accuracy. This method has been used to measure plasma lapatinib concentrations in a Phase I study in children with cancer. (c) 2005 Elsevier B.V. All rights reserved.
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