Stability-Indicating RP-HPLC Method for Analysis of Fenofibrate in the Bulk Drug and in a Pharmaceutical Dosage Form

A novel stability-indicating RP-HPLC method has been developed and validated for quantitative analysis of fenofibrate in the bulk drug and in a pharmaceutical dosage form. Use of a 250 mm×4.6 mm, 5μm particle, C18 column with 95:05%v/v acetonitrile and acetate buffer pH 5.0 as isocratic mobile phase enabled separation of the drug from its degradation products. UV detection was performed at 268 nm. The method was validated for linearity, accuracy (recovery), precision, specificity, and robustness. The linearity of the method was satisfactory over the range 10-50 μgmL^-1(correlation coefficient 0.9997). The limits of detection and quantification were 0.011 and 0.043 μgmL^-1, respectively. Recovery of fenofibrate from the pharmaceutical dosage form ranged from 100.6 to 104.1%. Fenofibrate was subjected to stress conditions (hydrolysis (acid, base), oxidation, photolysis, and thermal degradation) and the samples were analyzed by this method. The substance was unstable in basic conditions. The drug was stable under the other stress conditions investigated. The degradation products were well resolved from main peak. The forced degradation study prove the stability indicating power of the method and therefore, the validated method may be useful for routine analysis of fenofibrate as bulk drug, in respective dosage forms, for dissolution studies and as stability indicating assay method in pharmaceutical laboratories and industries.