Application of capillary electrophoresis-nano-electrospray ionization-mass spectrometry for the determination of N-nitrosodimethylamine in pharmaceuticals.
Capillary electrophoresis
Mass spectrometry
N-nitrosodimethylamine
Nano-electrospray ionization
Valsartan
Journal
Electrophoresis
ISSN: 1522-2683
Titre abrégé: Electrophoresis
Pays: Germany
ID NLM: 8204476
Informations de publication
Date de publication:
02 2021
02 2021
Historique:
received:
05
10
2020
revised:
10
12
2020
accepted:
11
12
2020
pubmed:
29
12
2020
medline:
16
10
2021
entrez:
28
12
2020
Statut:
ppublish
Résumé
After a presence of highly hepatotoxic and potentially carcinogenic N-nitrosodimethylamine was detected in certain lots of sartan, ranitidine, metformin, and other pharmaceuticals, local regulatory authorities issued recalls of suspected products, and concerns of the pharmacotherapy safety were widely discussed. Since then, testing of a representative sample of each produced lot of these pharmaceuticals is required as a part of quality control processes. Hence, an interface-free CE-nanoESI system coupled with MS detection was employed for the development of a simple and economical method for quantitative detection of this contaminant in the valsartan drug substances and finished formulations used as model matrices. In this arrangement, a fused-silica capillary was used as both a separation column and a nanoESI emitter providing high ionization efficiency and sensitivity. The optimized procedure was found to have sufficient selectivity, linearity, accuracy, and precision. The established LOD and LOQ values were 0.3 and 1.0 ng/mL, respectively. The practical applicability of the method was tested by analyses of commercially available Valsacor
Identifiants
pubmed: 33368407
doi: 10.1002/elps.202000303
doi:
Substances chimiques
Tablets
0
Valsartan
80M03YXJ7I
Dimethylnitrosamine
M43H21IO8R
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
334-341Informations de copyright
© 2020 Wiley-VCH GmbH.
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