Abstract
R-Besifloxacin hydrochloride is a novel chiral broad-spectrum fluoroquinolone developed for treatment of bacterial conjunctivitis and used in clinics due to its higher antibacterial activity compared to S-enantiomer. UHPLC separation of R- and S-enantiomers of Besifloxacin hydrochloride on a new Chiralpak IE-3 column consisting of an immobilized amylose tris(3,5-dichlorophenylcarbamate) chiral stationary phase on 3 µm silica was studied. The selection and effects of mobile phase solvents, additives, organic modifiers, and column temperature on retention, separation, and resolution were investigated and optimized. The separation was accomplished under normal-phase conditions using a mobile phase composed of dichloromethane:isopropyl alcohol:trifluoroacetic acid:diethylamine (90:10:0.3:0.05 v/v/v/v) under isocratic mode of elution at 15 °C. The interactions between the analytes, additives, and the stationary phase were discussed and the most probable separation mechanism was proposed. The developed method was validated according to ICH guidelines and found to be suitable for determining the enantiomeric purity of R-Besifloxacin in bulk drugs and formulations.
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