Characterization of stress degradation products of bedaquiline fumarate and bedaquiline by LC-PDA and LC-MS.


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:
25 Oct 2023
Historique:
received: 19 06 2023
revised: 15 08 2023
accepted: 16 08 2023
medline: 11 9 2023
pubmed: 25 8 2023
entrez: 24 8 2023
Statut: ppublish

Résumé

Bedaquiline fumarate was a first-in-class diarylquinoline drug used for the treatment of M. tuberculosis and its main biologically active form was bedaquiline. This paper studied and compared the degradation products of bedaquiline fumarate and bedaquiline using LC-PDA, LC-MS, and NMR techniques under thermal, alkaline, acidic, oxidative, and photolytic conditions respectively. A LC method was established and optimized to separate all analytes of bedaquiline fumarate and bedaquiline. All degradation products were identified by LC-HRMS/MS and LC-MS

Identifiants

pubmed: 37619292
pii: S0731-7085(23)00427-2
doi: 10.1016/j.jpba.2023.115658
pii:
doi:

Substances chimiques

bedaquiline 78846I289Y
Diarylquinolines 0
Fumarates 0

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

115658

Informations 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.

Auteurs

Kaijing Guo (K)

Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China.

Yanan Wang (Y)

Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China.

Chen Ma (C)

Institute of Materia Medica, Chinese Academy of Medical Science and Peking Union Medical College, Beijing 100050, China. Electronic address: mach@imm.ac.cn.

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Classifications MeSH