Concentration Determination of Sodium Valproate in Human Serum by HPLC-Fluorescence Detection Method / 中国药房

ABSTRACT

OBJECTIVE:To establish a method for the determination of sodium valproiate in human serum and to study the bioequivalence of steady state concentration C ssm in of the domestic and imported sodium valproiate sustained-release compound tablets.METHODS:Two periods of multi-oral administration of domestic and imported sodium valproiate sustained-release compound tablets were conducted alternately at random on20healthy male volunteers;the trough concentration of sodium valproate in human serum was determined by HPLC-fluorescence detection and the data were analyzed by3p97pro?gram.RESULTS:The blood concentration was steady after3d oral administration of both the domestic and imported sodium valproate sustained-release compound tablets.The C ssm in of domestic and imported products were(38.17?9.36)、(35.48?9.44)mg/L respectively.C ss min of domestic and imported sodium valproate sustained-release compound tablets were of bioe?quivalence either single or multi-oral administration.CONCLUSION:This HPLC-fluorescence method is quick,sensitive and economical,which can be used to monitor the concentration of sodium valproate in human serum.