Development and Validation of Stereo Selective Method for the Separation of Razoxane Enantiomers in Hydrophilic Interaction Chromatography.

A novel sensitive and high throughput chiral hydrophilic interaction chromatographic (HILIC) method was developed to separate razoxane enantiomers namely levrazoxane (R-isomer) and dexrazoxane (DEX) in pharmaceutical active ingredient samples. A systematic chiral chromatographic screening system was employed in using multiple HPLC chromatographic modes on various polysaccharide based chiral columns to obtain a potential separation between enantiomers. HPLC separation was achieved using a mobile phase of aqueous 10 mM ammonium bicarbonate and mixture of organic modifiers (70/30, v/v) in the ratio of (5/95, v/v) on an immobilized polysaccharide based chiral stationary phase namely CHIRALPAK IE-3.