Liquid chromatography-mass spectrometry in evaluation of bioequivalence of two kinds of amlodipine besylate tablets / 第二军医大学学报
Academic Journal of Second Military Medical University
;
(12)1981.
Article
in Chinese
| WPRIM
| ID: wpr-561136
ABSTRACT
Objective:
To establish a liquid chromatography-mass spectrometry(LC-MS) method for determining the concentration of amlodipine besylate in human plasma and to evaluate the bioequivalence of 2 kinds of amlodipine besylate tablets.Methods:
Twenty healthy male volunteers were enrolled into a single crossover study.A single dose of the suspension equivalent to 10 mg amlodipine besylate or a reference preparation was given in a crossover way.The plasma concentrations of amlodipine besylate were determined by LC-MS method in the volunteers at different time points;the pharmacokinetic parameters and relative bioavailability were calculated and the bioequivalence of the 2 preparations were evaluated.Results:
The pharmacokinetic parameters for experimental and the reference preparations were C_max(6.21?1.88) vs(6.03?1.08) ng/ml;AUC_0-120(250.68?52.61) vs(246.14?52.11) ng h/ml;T_max(6.0?2.3) vs(6.1? 2.5) h;t_1/2(40.45?6.68) vs(43.74?9.05) h,respectively.The linear range of the present method was 0.1-20.0 ng/ml;the lowest detectable concentration of amlodipine besylate was 0.1 ng/ml.There was no significant difference in pharmacokinetic parameters between the 2 tablets.Conclusion:
The present method is simple to use,fast,and accurate.The 2 preparations of amlodipine besylate are bioequivalent.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Academic Journal of Second Military Medical University
Year:
1981
Type:
Article
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