Pharmacokinetics and bioequivalence analysis of amlodipine tablets in Chinese female and male volunteers by HPLC-MS/MS

doi:10.5246/jcps.2017.04.030

Abstract

Abstract:

In the present study, we determined the pharmacokinetics and bioequivalence of two amlodipine tablets in Chinese male and female volunteers using HPLC-MS/MS method. A randomized, two-period and crossover design was conducted in 20 healthy volunteers (14 male subjects and six female subjects). A single dose of either the reference or test formulation was given at the start of each period. Blood samples were collected before drug administration and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 48, 72, 96, 120 and 144 h after drug administration. Plasma amlodipine was detected by HPLC-MS/MS method, and the pharmacokinetic parameters were analyzed using DAS 3.2.8. The developed HPLC-MS/MS method was suitable for the analysis of amlodipine in biological matrix samples. The main pharmacokinetic parameters between the trial preparation and the reference preparation met the regulatory criteria for bioequivalence, and the two preparations were both well tolerated.

Key words: Amlodipine, Pharmacokinetics, Bioequivalence, Tolerability, HPLC-MS/MS

CLC Number:

R969.1

Supporting:

Sisi Cao, Yang Deng, Hualin Cai, Zhenyan Hou, Miao Yan, Bikui Zhang. Pharmacokinetics and bioequivalence analysis of amlodipine tablets in Chinese female and male volunteers by HPLC-MS/MS[J]. Journal of Chinese Pharmaceutical Sciences, 2017, 26(4): 291-297.

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