Stable-Isotope Methodology in the Bioavailability Study of 17α-Methyltestosterone using Gas Chromatography-Mass Spectrometry

Autor: Shinohara, Yoshihiko, Baba, Shigeo, Kasuya, Yasuji, Knapp, Gene, Pelsor, Francis R., Shah, Vinod P., Honigberg, Irwin L.
Zdroj: Journal of Pharmaceutical Sciences; February 1986, Vol. 75 Issue: 2 p161-164, 4p
Abstrakt: The application of a stable-isotope coadministration technique for estimating the relative bioavailability of 17α-methyltestosterone is described. Eight healthy male subjects were administered orally a single 10-mg 17α-methyltestosterone tablet together with a 10-mg 17α-methyltestosterone-d3solution. The serum concentrations of 17α-methyltestosterone and 17α-methyltestosterone-d3were determined by gas chromatography-mass spectrometry with selected ion monitoring using 17α-methyltestosterone-d6as 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 17α-methyltestosterone.
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