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.
Zufía López
Laura
L
Pharmacy Department, University Hospital of Navarra, Pamplona, Spain. lzufia@unav.es
Aldaz Pastor
Azucena
A
Aramendia Beitia
Jose Manuel
JM
Arrobas Velilla
Juncal
J
Giraldez Deiró
Joaquín
J
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
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel