A Novel Method for Determination of Fenofibric Acid in Human Plasma using HPLC-UV: Application to a Pharmacokinetic Study of New FormulationsIltaf Shah1, James Barker2, Stephen J Barton2 and Declan P Naughton1*
- *Corresponding Author:
- Declan P Naughton
Faculty of Science, Engineering and Computing
School of Life Sciences, Kingston University, Penrhyn Road
Kingston-upon-Thames, Surrey, KT1 2EE, UK
Tel: +44 (0)208 417 7097
E-mail: [email protected]
Received date: December 16, 2013; Accepted date: February 28, 2014; Published date: March 04, 2014
Citation: Shah I, Barker J, Barton SJ, Naughton DP (2014) A Novel Method for Determination of Fenofibric Acid in Human Plasma using HPLC-UV: Application to a Pharmacokinetic Study of New Formulations. J Anal Bioanal Tech S12:009. doi: 10.4172/2155-9872.S12-009
Copyright: © 2014 Shah I, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
A high performance liquid chromatography method for the determination of fenofibric acid (FA), the active form of fenofibrate (FBT) in human plasma was developed and validated with 500 μL of human plasma using 4’-chloro- 5-fluro-2-hydroxybenzophenone (CFHB) as internal standard (IS). The assay procedure involved a simple one step liquid/liquid extraction of FA and IS from human plasma into ethyl acetate. The organic layer was separated and evaporated under a gentle stream of nitrogen at 40°C. The residue was reconstituted in the mobile phase and injected on a Symmetry ShieldÃ¯ÂÂRP18 (150×4.60 mm) 5 μm column. Separation of FA and IS was achieved with a mobile phase consisting of acetonitrile: 0.02 M phosphoric acid (50:50 v/v) at a flow rate of 1 mL/min. Nominal retention times of FA and IS were 6.1 and 9.1 ± 0.5 min, respectively. Absolute recovery of FA using a single step liquid/liquid method was 79.8%. A calibration curve was established for a range of concentrations 0.05 to 10.0 μg/mL with a regression coefficient (r2) of 0.9988. The lower limit of quantification (LLOQ) of FA was 0.05 μg/mL. The intraand inter-day precision for the measurement of FA quality control samples (0.05, 0.12, 1.20 and 8.20 μg/mL), were in the range 4.6-16.9% and 4.4-17.2% relative standard deviations respectively. The accuracy in the measurement of QC samples for FA was in the range of 82.0-104.3% (intra-day) to 95.0-104.9% (inter-day). The method developed was successfully used to investigate the pharmacokinetics and bioequivalence between a micronized Lipidil-Micro™ capsule formulation and a nanonised fenofibrate Lipidil-EZ™ tablet formulation.