The determination of miconazole and its related production impurities together with basic solution stability studies using a sub 2 μm chromatographic column

Abstract

A selective and sensitive method for the analysis of Miconazole and its associated impurities is developed. The separation is carried out using a Thermo Scientific Hypersil Gold C18 Column (50 mm × 4.6 mm i.d., 1.9 μm particle size) with a mobile phase of acetonitrilemethanolammonium acetate (1.5 w/v) (30:32:38 v/v) at a flow rate of 2.5 mL/min and UV detection at 235 nm. The method is validated according to ICH guidelines with respect to precision, accuracy, linearity, specificity, robustness, and limits of detection and quantification. All parameters examined are found to be well within the stated guidelines. Naturally aged samples are also tested to determine sample stability. A profile of sample and impurity breakdown was presented. The analysis time was more than halved from just under 20 min (the current European Pharmacopeia Method) to under 8 min (developed method) and the method is applicable for assay and related substance determination. © 2012 The Author.