title: High-performance liquid chromatographic determination of finasteride in human plasma using direct injection with column switching.
abstract: A fully automated column-switching high-performance liquid chromatographic (HPLC) method was developed for the quantification of finasteride [N-(1,1-dimethylethyl)-3-oxo-4-aza-5 alpha-androst-1-ene-17 beta- -carboxamide] in human plasma. Plasma samples were diluted with an equal volume of ethylene glycol-water (40:60, v/v), then the diluted sample (150 microliters) was injected into the HPLC system without clean-up. The analyte was retained on a pretreatment column, whereas plasma proteins and other endogenous components were washed out to waste. The analyte was transferred to the analytical column in the heart-cut mode and then detected at 210 nm. A quantification limit of 1 ng/ml was attained. There was a linear relationship between peak height and drug concentration in plasma in the range 1-50 ng/ml. This method was validated and applied to the assay of plasma samples to characterize pharmacokinetic parameters in clinical studies.
authors.affiliation: Drug Metabolism, Development Research Laboratories, Banyu Pharmaceutical Co. Ltd, Saitania, Japan.
authors.forename: T
authors.initials: T
authors.lastname: Takano
authors.forename: S
authors.initials: S
authors.lastname: Hata
mesh_terms: D001711:Biotransformation; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D004791:Enzyme Inhibitors / Q000097:blood* / Q000493:pharmacokinetics; D018120:Finasteride / Q000097:blood* / Q000493:pharmacokinetics; D008401:Gas Chromatography-Mass Spectrometry; D006801:Humans; D007202:Indicators and Reagents; D011786:Quality Control; D012015:Reference Standards; D012996:Solutions; D013056:Spectrophotometry, Ultraviolet
chemical_list: D004791:Enzyme Inhibitors; D007202:Indicators and Reagents; D012996:Solutions; D018120:Finasteride