METHOD DEVELOPMENT AND VALIDATION FOR FENOFIBRATE BY RP-HPLC METHOD

Develop a simple isocratic reverse phase high performance liquid chromatography (RPHPLC) method and validate for the determination of Fenofibrate in bulk and pharmaceutical dosage forms. RPHPLC quantification was carried out using Zorbax C-18 column (5µm, 150cm 4.6mm, ID) with a mobile phase comprising phosphate buffer (pH 3.0) : Acetonitrile in the ratio of 30:70 (% v/v) at a flow rate of 1.0 ml/min. The detection was carried out using a diode array detector at 285 nm. The % of Assay was found to be within the limits of 99-101. The % Recovery for each level around 99.5. The retention time was found to be 19.268 min and produced a linear response in the concentration range of 1-500 µg/mL (R2~0.999). The % RSD was found to be below 2%. The LOD and LOQ were found to be 0.228µg/ml and 0.764µg/ml respectively. Validation of the method was performed for precision, accuracy, linearity, ruggedness, specificity and sensitivity to conform to the ICH guidelines for validation of an analytical method

Keywords: Fenofibrate, RP-HPLC