Simultaneous determination of OSI-774 and its major metabolite OSI-420 in human plasma by using HPLC with UV detection |
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Authors: | Zhang Wenjiang Siu Lillian L Moore Malcolm J Chen Eric X |
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Institution: | Department of Experimental Therapeutics, Ontario Cancer Institute, Ontario, Canada. |
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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. |
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Keywords: | OSI-774 OSI-420 HPLC |
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