Pharmacokinetics of granisetron hydrocloride capsule in healthy volunteers
10.3724/SP.J.1008.2008.01395
- Author:
Zhen LI
1
Author Information
1. Department of Clinical Pharmacology
- Publication Type:Journal Article
- Keywords:
Granisetron hydrocloride;
LC/MS/MS;
Pharmacokinetics
- From:
Academic Journal of Second Military Medical University
2010;29(11):1395-1397
- CountryChina
- Language:Chinese
-
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, AUC0-024 (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.
