Behaviour of Tetrabenazine in Acid Medium: Reassessment and Impact on Formulation.
LC-MS
acid medium
degradation impurities
deuterated tetrabenazine
deuteration
orodispersible film
stability
synthesis
tetrabenazine
Journal
Pharmaceutics
ISSN: 1999-4923
Titre abrégé: Pharmaceutics
Pays: Switzerland
ID NLM: 101534003
Informations de publication
Date de publication:
20 Jan 2019
20 Jan 2019
Historique:
received:
14
12
2018
revised:
16
01
2019
accepted:
17
01
2019
entrez:
24
1
2019
pubmed:
24
1
2019
medline:
24
1
2019
Statut:
epublish
Résumé
Thorough studies of previous analytical stress data of tetrabenazine, a dopamine depleting agent, showed a potential susceptibility to acidic conditions. Hence, the behavior of tetrabenazine acidic solutions was studied by LC-MS and NMR spectroscopy. Reverse-phase LC-MS analysis of tetrabenazine acidic aqueous solutions consistently showed a main lipophilic impurity in a proportion of 15 to 20%. NMR spectroscopy studies did not allow to completely ascertain its structure. However, we hypothesize an interconversion of
Identifiants
pubmed: 30669539
pii: pharmaceutics11010044
doi: 10.3390/pharmaceutics11010044
pmc: PMC6359103
pii:
doi:
Types de publication
Journal Article
Langues
eng
Déclaration de conflit d'intérêts
The authors declare no conflict of interest.
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