Pharmacokinetics of granisetron hydrocloride capsule in healthy volunteers
Journal Title: Di-er Junyi Daxue Xuebao - Year 2008, Vol 29, Issue 11
Abstract
Objective:To establish a sensitive and specific LC/MS/MS method for the determination of granisetron in human plasma,and to apply it in investigating the pharmacokinetics of granisetron hydrocloride capsule in healthy volunteers.Methods: Twelve healthy male volunteers were given single oral dose of 2 mg granisetron hydrocloride capsules.The plasma concentrations of granisetron were determined by LC/MS/MS method after liquid-liquid extraction.The pharmacokinetic parameters were calculated by noncompartment model.Results: The calibration curve was linear within a concentration range of 0.501-20.04 ng/ml,with the limit of quantification being 0.501 ng/ml.The main pharmacokinetic parameters of granisetron in the volunteers were as following: Cmax(6.93±1.90) ng/ml,tmax(1.35±0.29) h,t1/2(5.59±1.87) h,MRT (8.05±1.84) h,Cl/F(54.23±16.08) L/h,AUC0-24 (36.61± 8.87) ng·h·ml-1 and AUC0-∞ (39.32±9.36) ng·h·ml-1.Conclusion: The present method is accurate,sensitive and reproducible for the determination of granisetron levels in human plasma.It is suitable for pharmacokinetic study of granisetron hydrochloride capsule in human.
Authors and Affiliations
zhen LI
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