title: Determination of docetaxel and Paclitaxel in human plasma by high-performance liquid chromatography: validation and application to clinical pharmacokinetic studies.
abstract: 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.
authors.affiliation: Pharmacy Department, University Hospital of Navarra, Pamplona, Spain. lzufia@unav.es
authors.forename: Laura
authors.initials: L
authors.lastname: Zufía López
authors.forename: Azucena
authors.initials: A
authors.lastname: Aldaz Pastor
authors.forename: Jose Manuel
authors.initials: JM
authors.lastname: Aramendia Beitia
authors.forename: Juncal
authors.initials: J
authors.lastname: Arrobas Velilla
authors.forename: Joaquín
authors.initials: J
authors.lastname: Giraldez Deiró
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics; D019540:Area Under Curve; D001943:Breast Neoplasms / Q000097:blood / Q000188:drug therapy; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D000077143:Docetaxel; D004355:Drug Stability; D005260:Female; D006207:Half-Life; D006801:Humans; D017239:Paclitaxel / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D011786:Quality Control; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet / Q000379:methods; D043823:Taxoids / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D013696:Temperature
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel