Pharmacokinetics of Domestic Cetirizine Hydrocloride Tablet in 11 Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:A reversed-phase high performance liquid chromatography(RP-HPLC)method was established to study the pharmacokinetics of cetirizine hydrocloride tablet in 11 healthy male volunteers METHODS:Waters HPLC instrument was used with the Waters symmetry C18 steeless column(3 9mm?150mm,5?m) The mobile phase was composed of acetonitrile-0 02mol/L sodium hydrogen diphosphate-triethylamine(50∶50∶0 16,V/V),which contained 4 0mmol/L sodium dodecyl sulphate Flow rate was 1 0ml/min Detection wavelength was 229nm Propafenone was taken as internal standard A single 10mg oral dose of cetirizine hydrocloride tablet was given to 11 healthy male volunteers Cetirizine concentration was assayed in plasma RESULTS:The standard curve of cetirizine hydrocloride was linear in the range of 12 5～800ng/ml The minimum detection limitation was 5ng/ml The extraction recovery was more than 75% A two-compartment open pharmacokinetic model was adapted in cetirizine plasma concentration-time data analysis The main pharmacokinetic parameters were as followsCmax=(429 00?108 80)ng/ml,Tmax=(0 91?0 40)h,AUC0～36(calculated by trapezoid method)=(3 312 72?682 39)ng/(h?ml) CONCLUSION:The method was accurate,sensitive and reliable It is applicable to determine the concentration of cetirizine hydrocloride in human plasma;The main pharmaconetic parameters of the domestic cetirizine hydrocloride tablet were similar to those reported at home and abroad,so it could be extensively used in clinic