Structural studies of racecadotril and its process impurities by NMR and mass spectroscopy.
Pharmazie
; 61(12): 994-8, 2006 Dec.
Article
in En
| MEDLINE
| ID: mdl-17283655
ABSTRACT
Three unknown impurities in racecadotril bulk drug at levels below 0.5% were detected by simple reverse phase isocratic high performance liquid chromatography (HPLC). Structures for these impurities were proposed by molecular ion information and their fragmentation pattern obtained by LC-MS and these impurities were confirmed by NMR spectroscopy. The impurities I, II and III were characterized as benzyl 2-methyl carboximido acetate, benzyl 2-phenyl ethyl carboximido acetate, and benzyl 2-(1-benzyl vinyl carboximido) acetate. These structures were further confirmed by co-injecting of synthetic standards of impurities with racecadotril. The mechanism of the formation of these process related impurities is discussed.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Thiorphan
Language:
En
Journal:
Pharmazie
Journal subject:
FARMACIA
Year:
2006
Document type:
Article
Affiliation country:
India