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Determination of amlodipine besylate in plasma and its pharmacokinetics by HPLC-MS-MS
Author(s): 
Pages: 776-780
Year: Issue:  4
Journal: Journal of Southwest University for Nationalities(Natrual Science Edition)

Keyword:  amlodipine besylateHPLC-MS-MSbioequivalence;
Abstract: Objective:To establish an HPLC-MS-MS method for determinating the concentration of amlodipine in human plasma, and to investigate the pharmacokinetics and bioequivalence of two amlodipine besylate tablets in Chinese healthy volunteer.Method:Two-way crossover trial is performed. Plasma samples are extracted with ether-dichlormethane mixed liquor (2: 1) and determined by HPLC-MS-MS.The main pharmacokinetic parameters and relative bioavailability are estimated by plasma concentration-time data, and the bioequivalence is evaluated.Result:The parameters of amlodipine for test and reference formulations are as follows:Cmax, 5.9511±2.3623 and 5.5517±1.9781 ng/mL;Tmax, 5.89±2.25 and 5.83±1.54 h;AUC(0-t), 195.6±79.4 and 212.7±72.1ng/mL·h,AUC(0-∞),226.1±91.2 and 240.3±82.3 ng/mL·method used in the study is sensitive, accurate and convenient.These 2 formulations of amlodipine besylate are bioequivalent.
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