Dissolution Determination of Ketotifen Fumarate Tablets

OBJECTIVE To establish an HPLC method for the determination of the dissolution of Ketotifen Fumarate tablets. METHODS The paddle method was used with 900 mL water as dissolution medium at the rotate speed of 50 r·min^-1. Inertsil ODS-SP column(4.6 mm×250 mm, 5 μm) was used with the mobile phase of methanol-water-triehylamine(950∶50∶ 0.02) at the detection wavelength of 300 nm. RESULTS The calibration curve of ketotifen fumarate was linear in the ange of 0.1-25 μg·mL^-1. The average recovery was 99.9% with RSD of 0.1%. CONCLUSION The inherent quality of the product can be objectively reflected in the above conditions. Furthermore, it has a significant distinction of the same agents from different sources.