Investigation of aclidinium bromide degradation by stability-indicating HPLC methods, characterization of impurities by NMR, and identification of degradation products by LC-MS.
Aclidinium bromide
Degradation
Impurity profiling
Stability-indicating methods
Stress testing studies
Journal
Journal of pharmaceutical and biomedical analysis
ISSN: 1873-264X
Titre abrégé: J Pharm Biomed Anal
Pays: England
ID NLM: 8309336
Informations de publication
Date de publication:
20 Jan 2024
20 Jan 2024
Historique:
received:
05
08
2023
revised:
29
10
2023
accepted:
02
11
2023
medline:
6
12
2023
pubmed:
10
11
2023
entrez:
10
11
2023
Statut:
ppublish
Résumé
Aclidinium bromide (ACL) is a long-acting muscarinic receptor antagonist used for the long-term treatment of chronic obstructive pulmonary disease (COPD). The aim of this study was to investigate the degradation of aclidinium bromide under stress and stability testing conditions, for which we developed and validated the first stability-indicating, specific, precise, accurate, and robust assay and related substances HPLC methods. Nine of the compounds used as reference standards were synthesized and fully characterized by
Identifiants
pubmed: 37948775
pii: S0731-7085(23)00614-3
doi: 10.1016/j.jpba.2023.115845
pii:
doi:
Substances chimiques
aclidinium bromide
UQW7UF9N91
Tropanes
0
Muscarinic Antagonists
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
115845Informations de copyright
Copyright © 2023 Elsevier B.V. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.