Enantioselective analysis of fluoxetine in pharmaceutical formulations by capillary zone electrophoresis

• Published in: Saudi pharmaceutical journal Vol. 25; no. 3; pp. 397 - 403
• Main Authors: Cârcu-Dobrin, Melania, Budău, Monica, Hancu, Gabriel, Gagyi, Laszlo, Rusu, Aura, Kelemen, Hajnal
• Format: Journal Article
• Language: English
• Published: Saudi Arabia Elsevier B.V 01.03.2017; Elsevier
• Subjects: Capillary electrophoresis; Chiral separation; Cyclodextrines; Fluoxetine; Original; Selective serotonin reuptake inhibitor; Cyclodextrines; Fluoxetine; Capillary electrophoresis; Chiral separation; Selective serotonin reuptake inhibitor
• ISSN: 1319-0164; 2213-7475
• DOI: 10.1016/j.jsps.2016.09.007

Fluoxetine is an antidepressant, a selective serotonin reuptake inhibitor (SSRI) used primarily in the treatment of major depression, panic disorder and obsessive compulsive disorder. Chiral separation of racemic fluoxetine is necessary due to its enantioselective metabolism. In order to develop a suitable method for chiral separation of fluoxetine, cyclodextrin (CD) modified capillary electrophoresis (CE) was employed. A large number of native and derivatized, neutral and ionized CD derivatives were screened to find the optimal chiral selector. As a result of this process, heptakis(2,3,6-tri-O-methyl)-β-CD (TRIMEB) was selected for enantiomeric discrimination. A factorial analysis study was performed by orthogonal experimental design in which several factors are varied at the same time to optimize the separation method. The optimized method (50mMphosphate buffer, pH=5.0, 10mMTRIMEB, 15°C, + 20kV, 50mbar/1s, detection at 230nm) was successful for baseline separation of fluoxetine enantiomers within 5min. Our method was validated according to ICH guidelines and proved to be sensitive, linear, accurate and precise for the chiral separation of fluoxetine.