title: High-performance liquid chromatographic method for the determination of finasteride in human plasma at therapeutic doses.
abstract: A high-performance liquid chromatographic (HPLC) method with ultraviolet detection for the determination of a novel 4-aza-steroidal inhibitor of 5 alpha-reductase in human plasma has been developed. The assay is based on a single solid-phase extraction and an efficient HPLC separation on two analytical columns in series. The assay has been fully validated and used to support Phase II and III clinical pharmacokinetic studies. The lowest limit of quantification was found to be at 1 ng/ml and allowed pharmacokinetic evaluation of the drug at doses down to 5 mg.
authors.affiliation: Merck Sharp & Dohme Research Laboratories, West Point, PA 19486.
authors.forename: M L
authors.initials: ML
authors.lastname: Constanzer
authors.forename: B K
authors.initials: BK
authors.lastname: Matuszewski
authors.forename: W F
authors.initials: WF
authors.lastname: Bayne
mesh_terms: D013741:3-Oxo-5-alpha-Steroid 4-Dehydrogenase / Q000008:administration & dosage; D058891:5-alpha Reductase Inhibitors; D000736:Androstenes / Q000097:blood* / Q000493:pharmacokinetics; D001378:Azasteroids / Q000097:blood* / Q000493:pharmacokinetics; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000706:statistics & numerical data; D004355:Drug Stability; D018120:Finasteride; D006801:Humans; D011786:Quality Control; D013810:Therapeutic Equivalency
chemical_list: D058891:5-alpha Reductase Inhibitors; D000736:Androstenes; D001378:Azasteroids; D018120:Finasteride; D013741:3-Oxo-5-alpha-Steroid 4-Dehydrogenase