Determination of Fenofibric Acid in Rat Plasma and its Application to a Comparative Pharmacokinetic Study of JW322 and Fenofibrate.

In this study, a sensitive and reliable method for the quantitation of fenofibric acid in rat plasma was developed and validated using high performance liquid chromatography (HPLC). The plasma samples were prepared by deproteinization, and sildenafil was used as an internal standard. Chromatographic separation was achieved using a reversed-phase (C18) column. The mobile phase, 0.02 M ammonium acetate buffer:acetonitrile (35:65, v/v), was run at a flow rate of 1.0 mL/min, and the column eluent was monitored using an ultraviolet detector at 280 nm at room temperature. The retention times of sildenafil (an internal standard), and fenofibric acid were approximately 5.9 and 7.7 min, respectively. The quantitation limit of fenofibric acid in rat plasma was 0.03 μg/mL. Pharmacokinetic parameters of fenofibric acid was evaluated after oral (at doses of 20 mg/kg) administration of JW322 and fenofibrate in rats. After oral administration (20 mg/kg) of JW322, relative bioavailability was approximately 272.8% compared to fenofibrate.