Advancing Bioanalytical Method Validation: A Comprehensive ICH M10 Approach for Validating LC-MS/MS to Quantify Fluoxetine in Human Plasma and Its Application in Pharmacokinetic Studies.
LC-MS-MS
bioanalysis
fluoxetine
pharmacokinetics application
validation
Journal
Molecules (Basel, Switzerland)
ISSN: 1420-3049
Titre abrégé: Molecules
Pays: Switzerland
ID NLM: 100964009
Informations de publication
Date de publication:
27 Sep 2024
27 Sep 2024
Historique:
received:
27
08
2024
revised:
19
09
2024
accepted:
25
09
2024
medline:
16
10
2024
pubmed:
16
10
2024
entrez:
16
10
2024
Statut:
epublish
Résumé
A fast and sample cleanup approach for fluoxetine in human plasma was developed using protein precipitation coupled with LC-MS-MS. Samples were treated with methanol prior to LC-MS-MS analysis. Chromatographic separation was performed on a reverse phase column with an isocratic mobile phase of methanol and 10 mM ammonium formate pH acidified with formic acid (80:20,
Identifiants
pubmed: 39407517
pii: molecules29194588
doi: 10.3390/molecules29194588
pii:
doi:
Substances chimiques
Fluoxetine
01K63SUP8D
Types de publication
Journal Article
Validation Study
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : Researchers Supporting Project number (RSPD2024R930), King Saud University, Riyadh, Saudi Arabia
ID : RSPD2024R930