E-Journal of Chemistry

SUNIL K DUBEY, MANOJ S. TOMAR, ANIL KUMAR PATNI, ARSHAD KHUROO, SIMRIT REYAR and TAUSIF MONIF

Department of Clinical Pharmacology and Pharmacokinetics, Ranbaxy Laboratories Ltd., Plot No. 20, Sector-18, Udyog Vihar Industrial Area, Gurgaon, Haryana, India.

Abstract:  The first, rapid and sensitive ultra performance liquid chromatography mass spectrometric method for the determination of fenofibric acid, the active metabolite of fenofibrate, a lipid regulating agent, in human EDTA plasma has been developed and validated using fenofibric d6 acid as internal standard and Waters LC-MS/MS. Negative ions of fenofibric acid and fenofibric d6 acid were detected in multiple reaction-monitoring (MRM) mode. The method was validated over a concentration range of 0.176 µg/mL to 19.837 µg/mL (r ≥ 0.99). It took only 1.5 minute to analyse a sample. Intra- and inter-run precision of fenofibric acid assay at four concentrations ranged from 0.5% to 4.3% with accuracy varied from 93.1 to 108.1% indicating good precision and accuracy. Analytical recoveries of fenofibric acid and internal standard in plasma were less than 90%. This method was successfully applied for evaluation of pharmacokinetics of fenofibric acid after a single oral dose of 145 mg fenofibrate to 10 Indian healthy volunteers

Keywords: Validation, LC-MS/MS, Fenofibric Acid, Pharmacokinetics, Lipid regulating agent

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