HPLC METHOD FOR THE ANALYSIS OF BOSENTAN AND RELATED SUBSTANCES AND USE OF THESE SUBSTANCES AS REFERENCE STANDARDS AND MARKERS Chromatography mass spectrometry fragmentation

摘要

Disclosed are bosentan degradation compounds A-E and their use as reference markers in a chromatographic method for testing the purity of a sample of bosentan. The compounds are: Compound A: N-[6-(2-(2-hydroxyethoxy)ethoxy)-5-hydroxy-2-(pyrimidin-2-yl)-pyrimidin-4-yl]-4-tert-butyl benzene sulphonamide. Compound B: N-[6-(ethene-1-oxy)-5-hydroxy-2-(pyrimidin-2-yl)-pyrimidin-4-yl]-4-tertbutyl benzene sulphonamide. Compound C: N-[6-(2-(2-hydroxyethoxy)ethoxy)-5-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)-pyrimidin-4-yl]-4-tert-butyl benzene sulphonamide. Compound D: N-[6-hydroxy-S-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)-pyrimidin-4-yl]-4-tert-butyl benzene sulphonamide. Compound E: N-[6-(ethene-1-oxy)-S-(2-methoxyphenoxy)-2-(pyrimidin-2-yl)-pyrimidin-4-yl]-4-tert-butyl benzene sulphonamide.