{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T21:10:58Z","timestamp":1791407458656,"version":"4.3.3"},"reference-count":26,"publisher":"MDPI AG","issue":"19","license":[{"start":{"date-parts":[[2024,9,27]],"date-time":"2024-09-27T00:00:00Z","timestamp":1727395200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"centre des \u00e9tudes de bioequivalence de la foundation cheikh zaid, Morocco","award":["RSPD2024R930"],"award-info":[{"award-number":["RSPD2024R930"]}]},{"name":"King Saud University, Riyadh, Saudi Arabia","award":["RSPD2024R930"],"award-info":[{"award-number":["RSPD2024R930"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Molecules"],"abstract":"<jats:p>A fast and sample cleanup approach for fluoxetine in human plasma was developed using protein precipitation coupled with LC\u2013MS-MS. Samples were treated with methanol prior to LC\u2013MS-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, v\/v) at a flow rate of 0.2 mL\/min. The run time was 4 min. Mass parameters were optimized to monitor transitions at m\/z [M + H]+ 310 &gt; &gt; 148 for fluoxetine and m\/z [M + H]+ 315.1 &gt; &gt; 153 for fluoxetine-d5 as an internal standard. The lower limit of quantification and the dynamic range were 0.25 and 0.25\u201350 ng\/mL, respectively. Linearity was good for intra-day and inter-day validations (R2 = 0.999). The matrix effect was acceptable with CV% &lt; 15 and accuracy% &lt; 15. The hemolytic effect was negligible. Fluoxetine was stable in human plasma for 48 h at room temperature (25 \u00b0C), for 12 months frozen at \u221225 \u00b0C, for 48 h in an auto-sampler at 6 \u00b0C, and for three freeze\/thaw cycles. The validated method was applied in a pharmacokinetic study to determine the concentration of fluoxetine in plasma samples. The study provides a fast and simple bioanalytical method for routine analysis and may be particularly useful for bioequivalence studies. The method was successfully applied to a pharmacokinetic study of fixed-dose fluoxetine in nine healthy volunteers.<\/jats:p>","DOI":"10.3390\/molecules29194588","type":"journal-article","created":{"date-parts":[[2024,9,27]],"date-time":"2024-09-27T06:10:27Z","timestamp":1727417427000},"page":"4588","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Advancing Bioanalytical Method Validation: A Comprehensive ICH M10 Approach for Validating LC\u2013MS\/MS to Quantify Fluoxetine in Human Plasma and Its Application in Pharmacokinetic Studies"],"prefix":"10.3390","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5352-2476","authenticated-orcid":false,"given":"Aimen","family":"El Orche","sequence":"first","affiliation":[{"name":"Laboratory of Drugs Sciences, Biomedical Research and Biotechnology, Faculty of Medicine and Pharmacy, Hassan II University of Casablanca, B.P. 9154, Casablanca 20250, Morocco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amine","family":"Cheikh","sequence":"additional","affiliation":[{"name":"Center for Bioequivalence Studies of the Sheikh Zaid Foundation, Av. Allal Al Fassi, Rabat 10000, Morocco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Choukri","family":"El Khabbaz","sequence":"additional","affiliation":[{"name":"Center for Bioequivalence Studies of the Sheikh Zaid Foundation, Av. Allal Al Fassi, Rabat 10000, Morocco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Houda","family":"Bouchafra","sequence":"additional","affiliation":[{"name":"Laboratory of Drugs Sciences, Biomedical Research and Biotechnology, Faculty of Medicine and Pharmacy, Hassan II University of Casablanca, B.P. 9154, Casablanca 20250, Morocco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"My El Abbes","family":"Faouzi","sequence":"additional","affiliation":[{"name":"Laboratory of Pharmacology and Toxicology, Biopharmaceutical and Toxicological Analysis Research Team, Faculty of Medicine and Pharmacy, Mohammed V University, Rabat 10000, Morocco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yahya","family":"Cherrah","sequence":"additional","affiliation":[{"name":"Center for Bioequivalence Studies of the Sheikh Zaid Foundation, Av. Allal Al Fassi, Rabat 10000, Morocco"},{"name":"Laboratory of Pharmacology and Toxicology, Biopharmaceutical and Toxicological Analysis Research Team, Faculty of Medicine and Pharmacy, Mohammed V University, Rabat 10000, Morocco"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3966-2282","authenticated-orcid":false,"given":"Siddique Akber","family":"Ansari","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6983-8587","authenticated-orcid":false,"given":"Hamad M.","family":"Alkahtani","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, P.O. Box 2457, Riyadh 11451, Saudi Arabia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoeb Anwar","family":"Ansari","sequence":"additional","affiliation":[{"name":"Department of Drug Science and Technology, University of Turin, 10124 Turin, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mustapha","family":"Bouatia","sequence":"additional","affiliation":[{"name":"Laboratory of Analytical Chemistry, Team of Formulation and Quality Control of Health Products, Faculty of Medicine and Pharmacy, Mohammed V University, Rabat 10000, Morocco"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2024,9,27]]},"reference":[{"key":"ref_1","unstructured":"(2023, November 08). 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