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



Tafesse TB1, 2, 3 ; Mazdeh FZ4 ; Chalipour A4 ; Tavakoli M4 ; Hajimahmoodi M4, 5 ; Amini M2
Authors
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Authors Affiliations
  1. 1. Pharmaceutical Sciences Research Center, Tehran University of Medical Sciences-International Campus (IC-TUMS), Tehran, Iran
  2. 2. Department of Medicinal Chemistry, Faculty of Pharmacy and Drug Design and Development Research Center, Tehran University of Medical Sciences, Tehran, Iran
  3. 3. School of Pharmacy, College of Health and Medical Sciences, Haramaya University, Harar, Ethiopia
  4. 4. Food and Drug Administration, Tehran University of Medical Sciences, Tehran, Iran
  5. 5. Drug and Food Control Department, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

Source: Chromatographia Published:2018


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. © 2018, Springer-Verlag GmbH Germany, part of Springer Nature.