Intra- and inter-species comparisons of biliary metabolic profiles of butoprozine by high performance liquid chromatography.

All detectable biliary butoprozine metabolites can be separated with a specially developed analytical approach based on gradient-elution reversed-phase h.p.l.c. without extraction steps. The high reproducibility of the h.p.l.c. systems allows preliminary intra- and inter-species comparisons based on retention times with single wavelength u.v. detection. Diode array u.v. spectrometry, radioactivity and mass-spectrometric measurements wee used to confirm the metabolic character of peaks in an individual chromatogram, and to obtain more evidence for the structure of metabolites with the same retention time in chromatograms of different bile fractions. Large inter-species differences in the biliary metabolic profiles are seen, indicating that great care must be exercised when trying to extrapolate preclinical drug safety evaluations from animals to man.