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Gas Chromatography–Mass Spectrometry Determination of Pregabalin in Human Plasma Using Derivatization Method

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Abstract

A gas chromatography–mass spectrometry method for the determination of pregabalin in human plasma is described. The procedure involves precipitation of protein, liquid–liquid extraction with ethylene glycol monomethyl ether, and derivatization with 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide in the presence of N-hydroxysuccinimide as additive. Separation was attained on HP column (30 m × 0. 25 mm ID, 0.25 μm) coupled with mass spectrometric detector using electron impact selected ion monitoring. The assay showed an excellent linearity in the concentration range of 0.36–10 μg mL−1 with correlation coefficient (r2) values of 0.999. The intra- and inter-day assay variations for three different concentration levels were less than 10%. The limit of quantification was detected at 0.36 μg mL−1. The method is highly specific, precise, accurate, and reproducible and could also be applied for the determination of pregabalin in human plasma.

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Acknowledgements

The authors acknowledged Food and drug Administration and Drug Design and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran, for their support by providing the necessary equipment’s and chemicals so as to complete the study. The current work was financially supported by Tehran University of Medical Sciences.

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Authors and Affiliations

  1. Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences-International Campus (IC-TUMS), Tehran, Iran

    Tadesse Bekele Tafesse

  2. Department of Medicinal Chemistry, Faculty of Pharmacy and Drug Design and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran

    Tadesse Bekele Tafesse & Mohsen Amini

  3. School of Pharmacy, College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia

    Tadesse Bekele Tafesse

  4. Food and Drug Administration, Tehran University of Medical Sciences, Tehran, Iran

    Fatemeh Zamani Mazdeh, Anita Chalipour, Mehdi Tavakoli & Mannan Hajimahmoodi

  5. Drug and Food Control Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

    Mannan Hajimahmoodi

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  1. Tadesse Bekele Tafesse
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  2. Fatemeh Zamani Mazdeh
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  3. Anita Chalipour
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  4. Mehdi Tavakoli
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  5. Mannan Hajimahmoodi
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  6. Mohsen Amini
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Correspondence to Mohsen Amini.

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The authors declare that there is no conflict of interests regarding the publication of this paper.

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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

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Tafesse, T.B., Mazdeh, F.Z., Chalipour, A. et al. Gas Chromatography–Mass Spectrometry Determination of Pregabalin in Human Plasma Using Derivatization Method. Chromatographia 81, 501–508 (2018). https://doi.org/10.1007/s10337-017-3458-0

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  • DOI: https://doi.org/10.1007/s10337-017-3458-0

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