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.


Journal

Molecules (Basel, Switzerland)
ISSN: 1420-3049
Titre abrégé: Molecules
Pays: Switzerland
ID NLM: 100964009

Informations de publication

Date de publication:
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

Auteurs

Aimen El Orche (A)

Laboratory of Drugs Sciences, Biomedical Research and Biotechnology, Faculty of Medicine and Pharmacy, Hassan II University of Casablanca, B.P. 9154, Casablanca 20250, Morocco.

Amine Cheikh (A)

Center for Bioequivalence Studies of the Sheikh Zaid Foundation, Av. Allal Al Fassi, Rabat 10000, Morocco.

Choukri El Khabbaz (C)

Center for Bioequivalence Studies of the Sheikh Zaid Foundation, Av. Allal Al Fassi, Rabat 10000, Morocco.

Houda Bouchafra (H)

Laboratory of Drugs Sciences, Biomedical Research and Biotechnology, Faculty of Medicine and Pharmacy, Hassan II University of Casablanca, B.P. 9154, Casablanca 20250, Morocco.

My El Abbes Faouzi (MEA)

Laboratory of Pharmacology and Toxicology, Biopharmaceutical and Toxicological Analysis Research Team, Faculty of Medicine and Pharmacy, Mohammed V University, Rabat 10000, Morocco.

Yahya Cherrah (Y)

Center for Bioequivalence Studies of the Sheikh Zaid Foundation, Av. Allal Al Fassi, Rabat 10000, Morocco.
Laboratory of Pharmacology and Toxicology, Biopharmaceutical and Toxicological Analysis Research Team, Faculty of Medicine and Pharmacy, Mohammed V University, Rabat 10000, Morocco.

Siddique Akber Ansari (SA)

Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.

Hamad M Alkahtani (HM)

Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia.

Shoeb Anwar Ansari (SA)

Department of Drug Science and Technology, University of Turin, 10124 Turin, Italy.

Mustapha Bouatia (M)

Laboratory of Analytical Chemistry, Team of Formulation and Quality Control of Health Products, Faculty of Medicine and Pharmacy, Mohammed V University, Rabat 10000, Morocco.

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Classifications MeSH