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Development and validation of an LC-ESI-MS/MS method for the simultaneous quantification of naproxen and sumatriptan in human plasma: application to a pharmacokinetic study

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Abstract

A sensitive and fast liquid chromatography-electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) method was developed and validated for the simultaneous quantification of naproxen and sumatriptan in human plasma. A simple liquid-liquid extraction procedure, with a mixture of ethyl acetate, methyl tert-butyl ether, and dichloromethane (4:3:3, v/v), was used for the cleanup of plasma. Naratriptan and aceclofenac were employed as internal standards. The analyses were carried out using an ACE C18 column (50 × 4.6 mm i.d.; particle size 5 μm) and a mobile phase consisting of 2 mM aqueous ammonium acetate with 0.025 % formic acid and methanol (38:62, v/v). A triple-quadrupole mass spectrometer equipped with an electrospray source in the positive mode was set up in the selective reaction monitoring mode to detect the ion transitions m/z 231.67 → m/z 185.07, m/z 296.70 → m/z 157.30, m/z 354.80 → m/z 215.00, and m/z 336.80 → m/z 97.94 for naproxen, sumatriptan, aceclofenac, and naratriptan, respectively. The method was validated and proved to be linear, accurate, precise, and selective over the ranges of 2.5–130 μg mL−1 for naproxen and 1–50 ng mL−1 for sumatriptan. The validated method was successfully applied to a pharmacokinetic study with simultaneous administration of naproxen sodium and sumatriptan succinate tablet formulations in healthy volunteers.

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Acknowledgments

The authors acknowledge Pró-Reitoria de Pesquisa at the UFMG for providing funds for publication and the Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) for providing scholarship and funds for research.

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Authors and Affiliations

  1. Faculdade de Farmácia, Universidade Federal de Minas Gerais (UFMG), Avenida Presidente Antônio Carlos 6627, Belo Horizonte, Minas Gerais, 31.270-901, Brazil

    Juliana Machado Brêtas, Isabela Costa César, Camila Machado Brêtas & Gerson Antônio Pianetti

  2. Instituto de Ciências Farmacêuticas, Alameda Coronel Eugênio Jardim 53, Aparecida de Goiânia, Goiás, 74.175-100, Brazil

    Leonardo de Souza Teixeira, Karini Bruno Bellorio & Iram Moreira Mundim

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  1. Juliana Machado Brêtas
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  2. Isabela Costa César
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  3. Camila Machado Brêtas
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  4. Leonardo de Souza Teixeira
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  5. Karini Bruno Bellorio
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  6. Iram Moreira Mundim
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  7. Gerson Antônio Pianetti
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Corresponding author

Correspondence to Isabela Costa César.

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Written consent was obtained from all of the volunteers after informing them about the objectives and possible risks involved in the study. The study protocol was approved by the Ethics Committee of the Instituto de Ciências Farmacêuticas.

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The authors declare that they have no conflict of interest.

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Brêtas, J.M., César, I.C., Brêtas, C.M. et al. Development and validation of an LC-ESI-MS/MS method for the simultaneous quantification of naproxen and sumatriptan in human plasma: application to a pharmacokinetic study. Anal Bioanal Chem 408, 3981–3992 (2016). https://doi.org/10.1007/s00216-016-9488-x

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  • DOI: https://doi.org/10.1007/s00216-016-9488-x

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