Determination of finasteride in human plasma by HPLC-MS

摘要

An assay employing liquid-liquid extraction followed by high-peifbimance liquid chromatography with positive ion Turbolonspray mass spectrometry (LC-MS) was developed and validated for the quantification of finasteride in human plasma to study the bioequivalence of finasteride oral disintegrated tablets with reference fmastetide tablets in human. The standard curve range in human plasma was 0.50-200 60 ng.ml~(-1) with a lower limit of quantification (LLOQ) verified at 0.50 ng ml~(-1) Inaccuracy was less than 9.1% and imprecision was less than 15% at all concentration levels. There was no interference from endogenous substances. The analyte was stable in human plasma following five freeze/thaw cycles and for up to 8 weeks following storage at -20degC,. The assay was successfully applied to the analysis of finasteride in human plasma samples derived from clinical trials, allowing the pharmacokinetics of the compound to be determined