STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF CHOLINE FENOFIBRATE IN PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

A simple, precise, accurate and stability indicating RP-HPLC method was developed and validated for the determination of choline fenofibrate in delayed release tablet dosage form. Separation was achieved under optimized chromatographic conditions on an inertsil ODS column (150 x 4.6 mm, 5µ particle size). The mobile phase consisted of potassium dihydrogen phosphate buffer pH 2.5 and acetonitrile in the ratio 32:68, an isocratic elution at a flow rate of 1.5mL/minute at ambient temperature. The detection was carried out at 300nm using Shimadzu UV-visible detector HPLC system. The retention time of fenofibrate was found at 3.70 minutes and the calibration curve was linear in the concentration range of 18-42µg/mL (r²=1). The limit of detection and the limit of quantification were found to be 2.40µg/mL and 7.28µg/mL respectively. The amount of fenofibrate present in dosage form was 100.9%. The proposed method was validated as per the ICH guidelines and during recovery studies the % recovery was found to be 98.37%. The method was found to be simple, linear, specific, rugged and suitable for the routine analysis of choline fenofibrate in the delayed release tablet dosage form.