RESUMEN
OBJECTIVE: To establish a method for isomer analysis of bepotastine besilate eye drops and test the stability of isomer in the preparation. METHODS: The analysis was performed on an ULTRON ES-CD chiral column (6.0 mm×150 mm, 5 μm). The mobile phase was 0.02 mol·L-1 potassium phosphate monobasic-acetonitrile(75∶25) at the flow of 0.8 mL·min-1. The column temperature was maintained at 35℃ and the detection wavelength was set at 225 nm. The injection volume was 10 μL. RESULTS: The limit of detection and limit of quantification of bepotastine besilate R-isomer were 12 and 48 ng, respectively. The linear range of bepotastine besilate R-isomer was 0.01-0.1 mg·mL-1 and the repeatability was good at high, medium and low concentrations. CONCLUSION: The method is simple and accurate, which can be used for isomer separation of bepotastine besilate and testing the stability of isomer in bepotastine besilate eye drops.