Development and Validation of Isocratic RP-UHPLC Method for Assay of Fenofibrate Tablet.

A method developed and validated for the assay of fenofibrate in tablet dosage form by isocratic RP-UHPLC-UV technique has been rapid and precise. The material was chromatographed on Shim-pack Velox C18 column (50 × 2.1 mm, 1.8 μm) at 40°C with isocratic mobile phase: acidified water/acetonitrile (60:40, v/v) at 0.4 mL/min and at a detection wavelength of 286 nm. The total run time was 6.0 min and fenofibrate eluted at ~2.4 min. The method was linear over 10-90 μg/mL (r2 = 0.9995) with LOD/LOQ of 0.239/0.673 μg/mL. The precision and accuracy (RSD less than 2% and 96%-100% recovery) comply with ICH Q2(R1) requirements both intra-day and inter-day. The present UHPLC method significantly shortens the analysis time and solvent consumption compared with the reported HPLC methods (typical run time > 8-20 min) without compromising of the sensitivity, which allows to use the present method for routine quality control of fenofibrate tablets.