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Stable-isotope Methodology in the Bioavailability Study of 17 Alpha-Methyltestosterone Using Gas Chromatography-Mass Spectrometry

Y Shinohara, S Baba, Y Kasuya, G Knapp, F R Pelsor, V P Shah, I L Honigberg

J Pharm Sci. 1986 Feb;75(2):161-4.

PMID: 3958925

Abstract:

The application of a stable-isotope coadministration technique for estimating the relative bioavailability of 17 alpha-methyltestosterone is described. Eight healthy male subjects were administered orally a single 10-mg 17 alpha-methyltestosterone tablet together with a 10-mg 17 alpha-methyltestosterone-d3 solution. The serum concentrations of 17 alpha-methyltestosterone and 17 alpha-methyltestosterone-d3 were determined by gas chromatography-mass spectrometry with selected ion monitoring using 17 alpha-methyltestosterone-d6 as an internal standard. The extent of absorption from the tablet formulation was comparable to that from the oral solution. The stable-isotope methodology was compared with the conventional cross-over method for evaluating the bioavailability of 17 alpha-methyltestosterone.

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