Development and validation of an LC-MS assay for finasteride and its application to prostate cancer prevention trial sample analysis

Xiaohong Chen, Erin R. Gardner, Douglas K. Price, William D. Figg

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

An analytical method is developed and validated for the quantitative determination of finasteride, a potent 5 α-reductase inhibitor, in human plasma. Calibration curves are linear in the concentration range of 1 to 100 ng/mL. Sample pretreatment involves a liquid-liquid extraction with ethyl acetate using 0.2 mL aliquots of plasma. Finasteride and the internal standard (beclomethasone) are separated on a Waters Symmetry Shield RP18 column (50 x 2.1 mm, 3.5 μm) and eluted using a gradient mobile phase composed of acetonitrile and 10mM ammonium acetate with 0.1% formic acid. The column eluant is monitored by mass spectrometry with electrospray ionization. A complete validation of the method is performed. For quality control samples at three different concentrations that were analyzed in quintuplicate, on six separate occasions, the accuracy and precision range from 95.2% to 101% and 3.4% to 7.3%, respectively. The developed method is subsequently applied to measure the steady state finasteride concentration of patients who participated in the Prostate Cancer Prevention Trial.

Original languageEnglish
Pages (from-to)356-361
Number of pages6
JournalJournal of Chromatographic Science
Volume46
Issue number4
DOIs
StatePublished - Apr 2008
Externally publishedYes

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