Determination of Related Substances of Fenofibrate Extended Release Capsules by HPLC

OBJECTIVE To establish an HPLC method for related substances determination of Fenofibrate Extended Release capsules. METHODS The Kromasil-100-5 C₁₈ column was used. The mobile phase was acetonitrile-water(pH 3.0) (67:33) at the flow rate of 1.0 mL·min^-1. The detection wavelength was 286 nm and column temperature was 40℃. The injection volume was 10 μL. RESULTS The separation of fenofibrate and its related substances was good. The calibration curves of fenofibrate was linear in the range of 0.54-3.23 μg·mL^-1(r=0.999 9), and its detection limit was 0.03 μg·mL^-1. CONCLUSION The method is rapid, accurate and reliable for related substances determination of Fenofibrate Extended Release capsules.