Strategies in developing high-throughput liquid chromatography protocols for method qualification of pharmacopeial monographs.
high-throughput analysis
method development
pharmaceuticals
superficially porous particles
ultrahigh pressure liquid chromatography
Journal
Journal of separation science
ISSN: 1615-9314
Titre abrégé: J Sep Sci
Pays: Germany
ID NLM: 101088554
Informations de publication
Date de publication:
Aug 2020
Aug 2020
Historique:
received:
08
04
2020
revised:
05
05
2020
accepted:
06
05
2020
pubmed:
11
5
2020
medline:
24
6
2021
entrez:
11
5
2020
Statut:
ppublish
Résumé
Method qualification is a key step in the development of routine analytical monitoring of pharmaceutical products. However, when relying on published monographs that describe longer method times based on older high-performance liquid chromatography column and instrument technology, this can delay the overall analysis process for generated drug products. In this study, high-throughput ultrahigh pressure liquid chromatography techniques were implemented to decrease the amount of time needed to complete a 24-run sequence to identify linearity, recovery, and repeatability for both drug assay and impurity analysis in 16 min. Multiple experimental parameters were tested to identify a range of experimental settings that could be used for the sequence while still maintaining this fast analysis time. The full sequence was replicated on a different system and with different columns, further demonstrating its robustness.
Identifiants
pubmed: 32388922
doi: 10.1002/jssc.202000403
doi:
Substances chimiques
Pharmaceutical Preparations
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2964-2970Subventions
Organisme : United States Department of Defense
Organisme : Science, Mathematics, and Research for Transformation (SMART)
Informations de copyright
© 2020 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
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