Abstract: A HPLC method was established to separate edoxaban tosilate hydrate and its related substances. SunFire C8(250 mm×4.6 mm, 5 μm)column was adopted in the analysis method and its temperature was kept at 30 ℃. The mobile phase A consisted of 20 mmol/L K₂HPO₄(pH 4.0)-acetonitrile(90∶10, V/V)and the mobile phase of B consisted of 20 mmol/L K₂HPO₄(pH 4.0)-acetonitrile(30∶70, V/V). A gradient elution at flow of 1.0 mL/min was used. The detection wavelength was 290 nm and the injection volume was 10 μL. The calibration curve of all substances were linear in appropriate concentration range, and the average recovery of all compounds were among 98.0%~102.0%, RSD(n=9)values were less than 2.0%. Each impurity was separated when the parameters had small changes and the assay variation of impurities was accepted. Methodology validation results proved that the method had good selectivity, high sensitivity, high accuracy and good robustness and it can be used for quality control of edoxaban tosilate hydrate.

Key words: edoxaban tosilate hydrate, related substances, HPLC, quality control