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      Development and validation of a rapid UHPLC-MS/MS method for the determination of fenofibric acid in human plasma: Application to a pharmacokinetic study of fenofibrate tablet in Chinese subjects

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          Abstract

          An ultra-high performance liquid chromatography-tandem mass spectrometry (UHPLC–MS/MS) method was developed to determine the fenofibric acid (FA) in human plasma and applied to a pharmacokinetic study of fenofibrate tablet (Lipanthyl® supra, 160 mg) on Chinese subjects which had not been reported. Bezafibrate was used as an internal standard (IS), and the plasma samples were precipitated by methanol. Multiple reaction monitoring (MRM) mode was used to quantitatively analyzed FA m/z 317.2 → 230.7 and the IS m/z 360.0 → 274.0 in the electrospray ionization (ESI) negative interface. The calibration curves were linear over the range of 50–30,000  ng/mL ( r 2  ≥  0.996). The intra-day and inter-day precision (coefficient of variation, CV%) was less than 2.7 and 2.5%, respectively. The accuracy (relative error, RE%) ranged from −4.5 to 6.9%. The average recovery was higher than 86.2%, and the matrix effect was between 95.32 and 110.55%. The simple, rapid, and selectivity method was successfully applied to the pharmacokinetic study of fenofibrate tablets on Chinese subjects.

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          Author and article information

          Contributors
          Journal
          1326
          Acta Chromatographica
          AChrom
          Akadémiai Kiadó (Budapest )
          2083-5736
          12 October 2020
          Affiliations
          [1 ] Bethune International Peace Hospital , No. 398 Zhongshan West Road, Shijiazhuang 050081, China
          [2 ] Shijiazhuang Maternity Hospital , No. 206 Zhongshan East Road, Shijiazhuang 050081, China
          [3 ] China Pharmaceutical University , No. 639 Longmian Road, Nanjing 211198, China
          Author notes
          [ * ]Corresponding author. biph2011@ 123456163.com
          Author information
          https://orcid.org/0000-0001-8325-0360
          Article
          10.1556/1326.2020.00792
          b680218b-62e0-40e3-9efd-e667cfc44cf9
          © 2020 The Authors

          Open Access. This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( https://creativecommons.org/licenses/by-nc/4.0/), which permits unrestricted use, distribution, and reproduction in any medium for non-commercial purposes, provided the original author and source are credited, a link to the CC License is provided, and changes – if any – are indicated.

          History
          : 09 May 2020
          : 08 September 2020
          Page count
          Figures: 3, Tables: 3, Equations: 0, References: 19, Pages: 06
          Categories
          Original Research Paper

          Materials properties,Nanomaterials,Chemistry,Nanotechnology,Analytical chemistry,Thin films & surfaces
          fenofibrate,UHPLC-MS/MS,pharmacokinetic study,fenofibric acid

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