DEVELOPMENT AND VALIDATION OF A STABILITY-INDICATING ULTRA-FAST LIQUID CHROMATOGRAPHIC ANALYSIS FOR THE SIMULTANEOUS DETERMINATION OF FENTICONAZOLE AND ITS RELATED SUBSTANCES IN PHARMACEUTICAL FORMULATIONS

Abstract

A precise stability-indicating an ultra-fast liquid chromatographic method was developed for determination of fenticonazole and its related substances in pharmaceutical formulations. Chromatographic separation was achieved on a C18 column (100 x 4mm, 3 mu m) under gradient elution by using mixture of 85% phosphoric acid solution adjusted to pH 3.0 using triethyamine and acetonitrile at a flow rate of 0.8 mL per minute. The analytes were detected using photodiode array detector at 235 nm. The retention time for fenticonazole was about 7.5 min. The drug was subjected to different stress conditions like hydrolysis (acid, alkaline and neutral), oxidation, photolysis and thermal degradation in accordance to ICH guidelines. A minor degradation was observed during oxidative hydrolysis. No degradation was observed under the other stress conditions. The method was validated for specificity, linearity, precision, accuracy, robustness, and system suitability. The method was linear in the drug concentration range of 5-150 mu g/mL with the correlation coefficient being 0.9985. The relative standard deviation for precision was below 2%. The mean recoveries were between 99.12-100.47% for drug substance. According to the obtained results, the method can successfully be applied for routine quality control analysis of fenticonazole in pharmaceutical formulation.