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

ABSTRACT 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 (r 2 = 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.