title: Liquid-chromatographic determination of erlotinib (OSI-774), an epidermal growth factor receptor tyrosine kinase inhibitor.
abstract: A high-performance liquid-chromatographic (HPLC) assay with UV detection has been developed for the quantitative determination of erlotinib (OSI-774) in human plasma. Quantitative extraction was achieved by a single-solvent extraction involving a mixture of acetonitrile and n-butyl chloride (1:4, v/v). Erlotinib and the internal standard hydrochloride salt (OSI-597) were separated on a column packed with Nova-Pak C18 material and a mobile phase composed of acetonitrile and water, pH 2.0 (60:40, v/v). The column effluent was monitored with dual UV detection at wavelengths of 348 nm (erlotinib) and 383 nm (OSI-597). The calibration graph was linear in the range of 100-4500 ng/ml, with values for accuracy and precision ranging from 87.9 to 96.2% and 2.13 to 5.10%, respectively, for three different sets of quality control samples. The developed method was successfully applied to study the pharmacokinetics of erlotinib in a cancer patient at the recommended daily dose of 150 mg.
authors.affiliation: Clinical Pharmacology Research Core, Medical Oncology Clinical Research Unit, and Cancer Therapeutics Branch, National Cancer Institute, 9000 Rockville Pike, Building 10, Room 5A01, Bethesda, MD 20892, USA.
authors.forename: Erin R
authors.initials: ER
authors.lastname: Lepper
authors.forename: Sandra M
authors.initials: SM
authors.lastname: Swain
authors.forename: Antoinette R
authors.initials: AR
authors.lastname: Tan
authors.forename: William D
authors.initials: WD
authors.lastname: Figg
authors.forename: Alex
authors.initials: A
authors.lastname: Sparreboom
mesh_terms: D001943:Breast Neoplasms / Q000188:drug therapy; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D066246:ErbB Receptors / Q000037:antagonists & inhibitors*; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D011799:Quinazolines / Q000097:blood* / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet
chemical_list: D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D066246:ErbB Receptors