Determination of Main Component in Megestrol Acetate Tablets by RP-HPLC / 中国药房

OBJECTIVE:To establish the RP-HPLC method for the determination of main component in megestrol acetate tablets.METHODS:RP-HPLC was carried out using a SinoChrom OPS-AP column with column temperature kept at room temperature.The detection wavelength was set at 288 nm.The mobile phase was composed of water-acetonitrile(20∶80,containing 2% triethylamine,pH 5.28)at a flow rate of 1.0 mL?min-1 with dixiben served as internal standard.The injection volume was 20 ?L.RESULTS:The standard curve was linear over the range of 7～336 ?g?mL-1 for megestrol acetate(r=0.999 6)and its recovery rate was 99.95%(RSD=0.51%).CONCLUSION:The method is simple,reproducible and accurate,and it is applicable for the determination of the megestrol acetate tablets.