HPLC-MS in evaluating bioequivalence of two kinds of aniracetam capsules in healthy volunteers
10.3724/SP.J.1008.2011.00053
- Author:
Lei LÜ
1
Author Information
1. Department of Pharmacy
- Publication Type:Journal Article
- Keywords:
4-p-anisamidobutyric acid;
Aniracetam;
Bioequivalence;
High pressure liquid chromatography-mass spectrometry
- From:
Academic Journal of Second Military Medical University
2011;32(1):53-57
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To establish a HPLC-MS method for determinating the concentration of 4-p-anisamidobutyric acid (ABA), the main active metabolite of aniracetam capsules in the plasma, and to compare the bioequivalence of two aniracetam capsules in healthy volunteers. Methods: Twenty-four healthy male volunteers were randomly given an oral single dose of 200 mg test or reference aniracetam capsules in a crossover manner. The concentrations of ABA were assayed by HPLC-MS at different time points. The main pharmacokinetic parameters and the relative bioavailability of two preparations were calculated, and their bioequivalence was evaluated. Results: The pharmacokinetic parameters of test and reference preparations were as follows: Cmax, being (9.30±5.13) and (8.70±3.17) μg/ml; tmax being (38.41±17.89) and (39.09±19.92) min; t1/2 being (37.21±10.51) and (38.45±9.24 ) min; AUC0-t being (555.21±157.10) and (545.39±97.22) μg/(ml·min), and AUC0-∞ being (566.24±158.01) and (554.71∞100.32) μg/(ml·min), respectively. Relative bioavailability F0-t and F0-∞ values of the test preparation were (101.22±17.17)% and (101.52±16.63)%, respectively. No significant differences were found in the main pharmacokinetic parameters between the two preparations. Conclusion: The two aniracetam preparations tested in the present study are bioequivalent.
