ESTIMATION OF IMPURITY PROFILES OF DRUGS AND RELATED MATERIALS .14. THE ROLE OF HPLC DIODE-ARRAY UV SPECTROSCOPY IN THE IDENTIFICATION OF MINOR COMPONENTS (IMPURITIES, DEGRADATION PRODUCTS, METABOLITES) IN VARIOUS MATRICES/

The possibility of the rapid identification of drug related minor comp onents by HPLC/diode-array UV spectroscopy is demonstrated by three ex amples. Hydroxylated impurities (degradation products) of norgestrel ( 6 alpha and beta, 10 beta-hydroxy derivatives) were identified on the basis of their UV spectra and retention matching with the synthesized impurities. The position of the phenolic hydroxyl groups in the mono- and dihydroxylated metabolites of bisaramil was established by UV spec troscopy and retention matching with the synthesized metabolites. The discrimination between the isomeric 4-ene-3-ketone and 1-ene-3-ketone components in crude 19-nortestosterone, product of the Birch reduction of 3-methoxy-1,3,5(10)-oestratriene-17 beta-ol, was also based on the diode-array UV spectra.