Liquid Chromatographic Assay for Fluoxymesterone in Human Serum with Application to a Preliminary Bioavailability Study

Fluoxymesterone was extracted from serum with a liquid–liquid extraction procedure. Serum containing both drug and internal standard, 6α-methylprednisolone, was extracted with methylene chloride. The extract was washed with 0.1M NaOH and water, evaporated, and reconstituted with mobile phase. Chroma...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 1985-03, Vol.74 (3), p.308-311
Main Authors: Capponi, V.J., Cox, S.R., Harrington, E.L., Wright, C.E., Antal, E.J., Albert, K.S.
Format: Article
Language:English
Subjects:
Adult
Analysis
Applied sciences
Biological and medical sciences
Biological Availability
Chromatography, High Pressure Liquid
Exact sciences and technology
Fluoxymesterone - blood
General pharmacology
Half-Life
Humans
Male
Medical sciences
Other techniques and industries
Pharmacology. Drug treatments
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Summary:Fluoxymesterone was extracted from serum with a liquid–liquid extraction procedure. Serum containing both drug and internal standard, 6α-methylprednisolone, was extracted with methylene chloride. The extract was washed with 0.1M NaOH and water, evaporated, and reconstituted with mobile phase. Chromatography was performed on a Zorbax Sil column, preceded by a guard column, with a mobile phase composed of 50% water-saturated butyl chloride:tetra-hydrofuran:methanol:phosphoric acid (880:100:15:0.5). Fluoxymesterone and methylprednisolone were detected by UV absorption at 236nm. Overall recovery was 80%. Calibration curves were linear for fluoxymesterone concentrations from 5 to 100ng/mL. The assay is accurate and precise (RSD values 7%); endogenous steroids did not interfere with the assay. Assay suitability was assessed in a bioavailability study in which six subjects each received two treatments of 10-mg fluoxymesterone tablets in a Latin-square crossover study. The two treatments were a tablet administered either buccally or orally. Cmax values ranged from 40 to 150ng/mL with tmax values of 1–2h. The harmonic mean half-life of fluoxymesterone was 2.0h. Less than 8% of the AUC was extrapolated. Mean Cmax and AUC values from the oral treatment were 80 and 76%, respectively, of the mean values from the buccal treatment.
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.2600740317