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  • P-ISSN 1225-0163
  • E-ISSN 2288-8985

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    Determination of nadolol enantiomers in human plasma using a coupled achiral-chiral high-performance liquid chromatography method

    Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
    2020, v.33 no.2, pp.59-67
    https://doi.org/10.5806/AST.2020.33.2.59
    Seung-Beom Lee (College of Pharmacy, Kangwon National University)
    Thuy-Vy Pham (College of Pharmacy, Kangwon National University)
    Xuan-Lan Mai (College of Pharmacy, Kangwon National University)
    Thi-Anh-Tuyet Le (College of Pharmacy, Kangwon National University)
    Thi-Ngoc-Van Nguyen (Pharmacy Faculty, Can Tho University of Medicine and Pharmacy, Vietnam)
    Jong-Seong Kang (College of Pharmacy, Chungnam National University)
    Woongchon Mar (Natural Products Research Institute, College of Pharmacy, Seoul National University)
    Kyeong Ho Kim (College of Pharmacy, Kangwon National University)
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    Abstract

    Nadolol is a β-blocker drug, which effectively manages hypertension and angina pectoris. Its chemical structure allows the formation of four possible stereoisomers. A coupled column high-performance liquid chromatographic (HPLC) system with UV and fluorescence detection was investigated for simultaneously determining four nadolol enantiomers in human plasma. The plasma samples were prepared using a convenient liquid-liquid extraction process and passed through HPLC. Nadolol was initially separated from the endogenous compounds or other impurities in human plasma on a Phenomenex silica column, and its enantiomers were resolved and determined on a Chirapak AD-H column. The developed HPLC method achieved an effective chiral separation and significantly eliminated endogenous compound interference. This optimal HPLC method was validated following FDA guidelines. The results showed good selectivity, linearity, accuracy (90.50 % – 105.27 %), and precision (RSDs < 9.52 %) for each enantiomer. This method was also successfully applied to determine nadolol enantiomers in the plasma samples of a healthy male volunteer (after orally administering 80 mg racemic nadolol), proving its suitability for nadolol stereoselective pharmacokinetic studies.

    keywords
    Nadolol, <TEX>${\beta}$</TEX>-blocker, stereoselective analysis, coupled achiral-chiral HPLC, pharmacokinetic study


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