Quality assessment of fluoxetine and fluvoxamine pharmaceutical formulations purchased in different countries or via the Internet by 19F and 2D DOSY 1H NMR

Journal of Pharmaceutical and Biomedical Analysis
Saleh TrefiRobert Martino

Abstract

A simple and selective (19)F NMR method has been validated for the quantitation of fluoxetine (FLX) and fluvoxamine (FLV) in methanol solutions and in human plasma and urine. The regression equations for FLX and FLV showed a good linearity in the range of 1.4-620 microg mL(-1) (3.3 x 10(-6)-1.8 x 10(-3) mol L(-1)) with a limit of detection of approximately 0.5 microg mL(-1) (1.3 x 10(-6) mol L(-1)) and a limit of quantification of approximately 2 microg mL(-1) (4.6 x 10(-6) mol L(-1)). The precision of the assay depends on the concentrations and is comprised between 1.5 and 9.5% for a range of concentrations between 1.2 x 10(-3) and 3.2 x 10(-6) mol L(-1). The accuracy evaluated through recovery studies ranged from approximately 96 to 103% in methanol solutions and in urine, and from approximately 93 to 104% in plasma, with standard deviations <7.5%. The low sensitivity of the method precludes its use for the assay of these antidepressants in biofluids at least at therapeutic doses as the ranges of FLX and FLV plasma levels are 0.15-0.5 microg mL(-1) and 0.15-0.25 microg mL(-1), respectively. The method was applied successfully to the determination of FLX and FLV contents in pharmaceutical samples (brand-named and generic) purc...Continue Reading

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Citations

May 4, 2010·Analytical and Bioanalytical Chemistry·R MartinoS Balayssac
Apr 10, 2012·Journal of Natural Products·Guido F PauliDavid C Lankin
May 24, 2014·Journal of Pharmaceutical and Biomedical Analysis·Rubén M MaggioTeodoro S Kaufman
Apr 29, 2014·Journal of Pharmaceutical and Biomedical Analysis·Ulrike Holzgrabe, Myriam Malet-Martino
Dec 3, 2016·Chemical Communications : Chem Comm·Pinelopi MoutzouriGareth A Morris
Sep 22, 2009·Magnetic Resonance in Chemistry : MRC·Edilene Delphino RodriguesGil Valdo José da Silva
Oct 12, 2010·Natural Product Reports·Ramon Novoa-CarballalRicardo Riguera
Jan 28, 2014·Magnetic Resonance in Chemistry : MRC·Guilherme Dal PoggettoCláudio F Tormena
Apr 11, 2020·Molecules : a Journal of Synthetic Chemistry and Natural Product Chemistry·Damjan MakucZdenko Časar
Jul 31, 2013·The Journal of Physical Chemistry. a·Denize C FavaroCláudio F Tormena
Oct 31, 2017·Analytical Chemistry·Pinelopi MoutzouriGareth A Morris
Oct 30, 2018·Analytical Chemistry·Guilherme Dal PoggettoMathias Nilsson

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