Determination of docetaxel and Paclitaxel in human plasma by high-performance liquid chromatography: validation and application to clinical pharmacokinetic studies.

Taxanes, docetaxel and paclitaxel, represent important antineoplastic agents with broad spectra of antitumor activity. The authors developed and validated a high-performance liquid chromatography method with ultraviolet detection for quantifying both taxanes in human plasma. The assay uses liquid-liquid extraction as sample treatment and an isocratic mobile phase and reversed-phase chromatography to determine docetaxel with paclitaxel as internal standard and vice versa. The lower limit of quantification was 0.015 mg/L. The assay had good recovery (87.96+/-14.05 and 90.57+/-9.63 for docetaxel and paclitaxel respectively) and precision: the within-day and between-days relative standard deviation of the mean for docetaxel (0.015-3 mg/L) and paclitaxel was always <10%. The method presented has been fully validated following the U.S. Food and Drug Administration requirements and has been successfully applied for the pharmacokinetic investigation of docetaxel or paclitaxel.