Estimation of impurity profiles of drugs and related materials. Part 14: the role of HPLC/diode-array UV spectroscopy in the identification of minor components (impurities, degradation products, metabolites) in various matrices.

Abstract:

:The possibility of the rapid identification of drug related minor components by HPLC/diode-array UV spectroscopy is demonstrated by three examples. 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 spectroscopy 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.

journal_name

J Pharm Biomed Anal

authors

Görög S,Bihari M,Csizér E,Dravetz F,Gazdag M,Herényi B

doi

10.1016/0731-7085(95)01579-5

subject

Has Abstract

pub_date

1995-12-01 00:00:00

pages

85-92

issue

1-2

eissn

0731-7085

issn

1873-264X

pii

0731-7085(95)01579-5

journal_volume

14

pub_type

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