Development and Validation of Liquid Chromatography Method for Simultaneous Estimation of Miconazole and Clobetasol and Characterization of Hydrolytic Degradation Products using Liquid Chromatography with Tandem Mass Spectrometry

A reverse phase high performance liquid chromatography method was developed to estimate Miconazole nitrate and Clobetasol propionate simultaneously from a cream formulation. The validated as per International Council for Harmonisation guidelines. proposed effectively applied the characterization of degradation products formed under hydrolytic stressed conditions. major degradants by hydrolysis both analytes were separated, identified characterized. Both drugs found susceptible acid base conditions while stable neutral hydrolysis. with tandem mass spectrometry studies further carried out on samples that provided accurate masses drug their products. spectral data fragmentation patterns explored characterize assign structures them. Total nine characterized pathways proposed.