Study on the Determination for the Content of Progesterone and Hydroxypropyl-β-cyclodextrin in Progesterone Injection
OBJECTIVE To establish a method of detecting the content of progesterone and hydroxypropyl-β-cyclodextrin in progesterone injection by high performance liquid chromatography and differential refractive index de-tector(HPLC-RID).METHODS The sample was separated on the size exclusion chromatograph column(Advance-Bio SEC 130Å,7.8 mm × 300 mm,2.7 µm),by using acetonitrile-water(20∶80)as the mobile phase at a flow rate of 0.8 mL·min-1 and at 35 ℃.The detector was RID and the temperature was 40 ℃.RESULTS The linear range of progesterone was 0.0252-0.0757 mg·mL-1,and of hydroxypropyl-β-cyclodextrin was 0.286-0.858 mg·mL-1(r=0.9999).The average recovery rate were 100.1％and 100.4％and RSD were 0.3％and 0.4％(n=9).CONCLUSION The method is simple,feasible and reliable with accurate results,which can be used to control the quality for progesterone injection.
万方数据
维普
