Quantifying methionine sulfoxide in therapeutic protein formulation excipients as sensitive oxidation marker.
Methionine sulfoxide
Method qualification
Mixed-mode chromatography
Oxidation
Therapeutic proteins
Trace analysis
Journal
Journal of chromatography. B, Analytical technologies in the biomedical and life sciences
ISSN: 1873-376X
Titre abrégé: J Chromatogr B Analyt Technol Biomed Life Sci
Pays: Netherlands
ID NLM: 101139554
Informations de publication
Date de publication:
15 Jan 2022
15 Jan 2022
Historique:
received:
04
11
2021
revised:
17
12
2021
accepted:
26
12
2021
pubmed:
14
1
2022
medline:
8
2
2022
entrez:
13
1
2022
Statut:
ppublish
Résumé
Methionine is a common excipient used in therapeutic protein liquid formulations as stabilizer and antioxidant. The oxidation of methionine to methionine sulfoxide can be regarded as a sensitive marker of oxidative stress for drug product storage conditions. In this study, a sensitive HPLC method for the quantification of methionine sulfoxide in formulated protein product was developed and qualified according to regulatory requirements using a SIELC® Primesep 100 column with UV detection. The separation involves a mixed-mode mechanism including reversed phase and cationic exchange modalities. The operating range of the method was established between 1 µM and 35 µM of methionine sulfoxide. In this testing range, the method was shown to be linear (R
Identifiants
pubmed: 35026663
pii: S1570-0232(21)00573-0
doi: 10.1016/j.jchromb.2021.123092
pii:
doi:
Substances chimiques
Biomarkers
0
Excipients
0
Methionine
AE28F7PNPL
methionine sulfoxide
XN1XVI4B2C
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
123092Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.