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  • Analytical procedure for the determination of the new antitumour drug N-benzoylstaurosporine and three potential metabolites in human plasma by reversed-phase high-performance liquid chromatography.

Analytical procedure for the determination of the new antitumour drug N-benzoylstaurosporine and three potential metabolites in human plasma by reversed-phase high-performance liquid chromatography.

Journal of chromatography. B, Biomedical applications (1995-05-19)
R van Gijn, O van Tellingen, J J de Clippeleir, M J Hillebrand, E Boven, J B Vermorken, W W ten Bokkel Huinink, S Schwertz, P Graf, J H Beijnen
RESUMEN

The staurosporine derivative, N-benzoylstaurosporine (CGP 41 251; I), is a protein kinase C inhibitor that has been selected for phase I clinical evaluation in cancer patients. We have developed a selective and sensitive assay of the drug and three potential metabolites in human plasma. The method is based on reversed-phase high-performance liquid chromatography with fluorescence detection. The sample pretreatment involves liquid-liquid extraction with diisopropyl ether with recoveries over 88%. The limit of detection and limit of quantitation of the parent compound and two metabolites were 0.5 and 1.0 ng/ml, respectively. For the third metabolite the limit of detection and limit of quantitation were 1.0 and 2.0 ng/ml, respectively. Linear calibration lines were obtained over the range of 1-1000 ng/ml. The between-day and within-day precisions were < 7.1% for all the analytes. In plasma the compounds were stable for at least one month if stored at -30 degrees C or below. The applicability of the method for in vivo studies has been demonstrated in a pharmacokinetic study in rat receiving 0.5 mg/kg of the drug as an intravenous bolus injection. Compound I and two metabolites were detected.

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Diisopropyl ether, puriss. p.a., ≥98.5% (GC)
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Diisopropyl ether, ReagentPlus®, 99%, contains either BHT or hydroquinone as stabilizer
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Diisopropyl ether, contains either BHT or hydroquinone as stabilizer, ACS reagent, ≥99.0%
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Diisopropyl ether, contains either BHT or hydroquinone as stabilizer, ACS reagent, ≥99.0%
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Diisopropyl ether, anhydrous, 99%, contains either BHT or hydroquinone as stabilizer
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Diisopropyl ether, analytical standard
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Diisopropyl ether, SAJ first grade, ≥99.0%
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Diisopropyl ether, JIS special grade, ≥99.0%
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