Development and validation of a simple stability-indicating high performance liquid chromatographic method for the determination of miconazole nitrate in bulk and cream formulations

Abstract

A simple and stability-indicating high performance liquid chromatographic method was developed and validated for the determination of miconazole nitrate in bulk and cream preparations. The extraction step for cream samples consisted in a warming, cooling and centrifugation procedure that assures the elimination of the lipophilic matrix component, in order to avoid further precipitation in the chromatographic system. Separation was achieved on a ZORBAX Eclipse XDB ? C18 (4.6mm×150mm, 5m particle size) column, using a mobile phase consisting of water, methanol and acetonitrile, in a flow and solvent gradient elution for 15 min. The column was maintained at 25 ◦C and 10L of solutions were injected. UV detection was performed at 232 nm, although employment of a diode array detector allowed selectivity confirmation by peak purity evaluation. The methodwas validated reaching satisfactory results for selectivity, precision and accuracy. Degradation products in naturally aged samples could be simultaneously evaluated, without interferences in the quantitative analysis.