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Determination of Fenofibric Acid in Human Plasma by LC–MS/MS and LC–UV

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Abstract

A sensitive, high-throughput and economic liquid chromatographic method for determination of fenofibric acid in human plasma was developed and validated by ultraviolet detection and tandem mass spectrometry, then applied in pharmacokinetic study to investigate Lipanthyl™ 200 mg MC bioavailability under food and fasting conditions. Fenofibric acid with 2-chloro fenofibric acid-d6 (internal standard) was extracted from 100 µL of human plasma by acetonitrile in a single extraction step. 25 and 2 µL from supernatant were injected onto ACE column, 50 mm, 5 micron with 4.6 mm inner diameter for LC–UV and 2.1 mm for LC–MS/MS, and both systems were eluted isocratically by water:methanol:formic acid (35:65:0.1, v/v/v), with a constant flow rate of 1 mL min−1. The established calibration curve was linear between 0.05–20 µg mL−1, and the within- and between-day precisions were all below 13 % in both LC–MS/MS and LC–UV systems during validation, and accuracies ranged between 91 and 112 %. Twenty-eight healthy adult subjects participated in this clinical study, and the pharmacokinetic parameters including coefficient of variation were calculated and discussed. A dramatic decrease in C max and AUC0-72 (3.63- and 1.85-fold, respectively) were observed for Lipanthyl™ MC under fasting conditions with more variable inter subject measurements comparing to the fed state.

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Acknowledgments

This research work was achieved in Jordan center for pharmaceutical research (Amman, Jordan), and we are grateful to the University of Duisburg-Essen/Faculty of Chemistry, (Essen, Germany) for their research facility.

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Authors and Affiliations

  1. Faculty of Pharmacy, Universitiy of Petra, Amman, Jordan

    Tawfiq Arafat

  2. Faculty of pharmacy and medical sciences, Al-Ahliyya Amman University, Amman, Jordan

    Basil Arafat

  3. Faculty of Chemistry, University of Duisburg-Essen, Essen, Germany

    Ahmad Abu Awwad & Oliver J. Schmitz

Authors
  1. Tawfiq Arafat
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  2. Basil Arafat
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  3. Ahmad Abu Awwad
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  4. Oliver J. Schmitz
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Correspondence to Ahmad Abu Awwad.

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Arafat, T., Arafat, B., Abu Awwad, A. et al. Determination of Fenofibric Acid in Human Plasma by LC–MS/MS and LC–UV. Chromatographia 79, 685–692 (2016). https://doi.org/10.1007/s10337-016-3080-6

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  • DOI: https://doi.org/10.1007/s10337-016-3080-6

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