Simultaneous Determination of Two Constituents in Ezetimibe and Simvastatin Tablets by HPLC

OBJECTIVE To establish an HPLC method for simultaneous determination of ezetimibe and simvastatin in ezetimibe and simvastatin tablets. METHODS The chromatographic separation was achieved on a Phenomenex Luna Phenyl Hexyl column(4.6 mm×150 mm, 5 μm) with acetonitrile-0.02 mol·L^-1 sodium dihydrogen phosphate (pH 4.5) as mobile phase, gradient elution, at the flow rate of 1.0 mL·min^-1. The detective wavelength was 231 nn and the temperature of column was 30 ℃. RESULTS The calibration curves of ezetimibe and simvastatin were linear in the range of 10.0-100.0 μg·mL^-1(r=0.999 8), 20.0-200.0 μg·mL^-1(r=0.999 9), respectively. The average recoveries of ezetimibe and simvastatin were 99.5%, RSD=1.3%(n=9) and 99.8%, RSD=0.9%(n=9), respectively. CONCLUSION The method is simple, reliable and accurate for simultaneous determination of ezetimibe and simvastatin in ezetimibe and simvastatin tablets.