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.
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.
Görög
S
S
Chemical Works of Gedeon Richter Ltd., Budapest, Hungary.
Bihari
M
M
Csizér
E
E
Dravetz
F
F
Gazdag
M
M
Herényi
B
B
D019086:Bridged Bicyclo Compounds, Heterocyclic / Q000032:analysis; D002722:Chlorobenzenes; D002851:Chromatography, High Pressure Liquid; D004340:Drug Contamination; D006900:Hydroxylation; D007202:Indicators and Reagents; D009640:Norethindrone / Q000032:analysis; D009644:Norgestrel / Q000032:analysis; D004364:Pharmaceutical Preparations / Q000032:analysis*; D013056:Spectrophotometry, Ultraviolet; D013256:Steroids / Q000032:analysis
D019086:Bridged Bicyclo Compounds, Heterocyclic; D002722:Chlorobenzenes; D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations; D013256:Steroids; D009644:Norgestrel; C045644:bisaramil; D009640:Norethindrone