Simultaneous determination of OSI-774 and its major metabolite OSI-420 in human plasma by using HPLC with UV detection

Zhang, W.; Siu, L.L.; Moore, M.J.; Chen, E.X.

Journal of Chromatography. B Analytical Technologies in the Biomedical and Life Sciences 814(1): 143-147

2005


ISSN/ISBN: 1570-0232
PMID: 15607718
DOI: 10.1016/j.jchromb.2004.10.016
Accession: 012559376

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Abstract
A new method was developed and validated for quantitating OSI-774 and its metabolite OSI-420 in human plasma. Sample preparation involved initial extraction with methyl t-butyl ether followed by back extraction with HCl and re-extraction with methyl t-butyl ether. This extraction process resulted in significant improvement in the specificity, reproducibility and sensitivity. The analytes were separated on a Water Symmetry C18 analytical column and the mobile phase consisted of acetonitrile-0.05 M potassium phosphate buffer (42:58, v/v) (pH 4.8), and monitored at a wavelength 345 nm. Values of between- and within-day precision and accuracy for both OSI-774 and OSI-420 were <20%. This method was successfully applied to study steady-state pharmacokinetics of OSI-774 and OSI-420 in a phase II clinical trial.