Application of HILIC stationary phase to determination of dimethindene maleate in topical gel.

A novel high performance liquid chromatography method for the determination of dimethindene maleate in pharmaceutical gel using hydrophilic interaction liquid chromatography (HILIC) with UV detection was developed and validated. Following optimal conditions for the analysis of dimethindene maleate were used: analytical column SeQuant ZIC-HILIC (50mmx2.1mm, 5microm), and mobile phase consisted of a mixture of acetonitrile and aqueous solution of acetic acid (25mM) and ammonium acetate (2.5mM) (87.5:12.5, v:v). The analysis time was less than 3min at a flow rate of 0.3mlmin(-1). UV detection was performed at 258nm. The method was validated and system suitability parameters were evaluated. The method is suitable for application for routine determination of dimethindene maleate in topical pharmaceutical preparation.