Title: Pharmacokinetics and bioequivalence study of levamlodipine besylate by UFLC-MS/MS
Abstract: Objective:To evaluate the bioequivalence of levamlodipine besylate tablets in healthy volunteers.Methods:A total of 19 healthy volunteers received a single oral 5 mg dose of levamlodipine besylate tablets in a random crossover design.The concentration of levamlodipine in the plasma was determined by UFLC-MS/MS.Results:The linear range of levamlodipine in plasma was 0.1~10.0 ng·mL-1,and the lower limit of quantification was 0.1 ng·mL-1.The main pharmacokinetic parameters of the test and reference tablets were as follows: Cmax were(2.842±0.428)and(2.891±0.444) ng·mL-1;t1/2 were(47.14±19.08)and(42.27±14.43) h;Tmax were(6.211±1.813)and(5.947±1.870) h;AUC0~t were(133.5±26.8)and(141.9±42.0) ng·mL-1·h-1;AUC0~∞ were(156.3±31.3)and(158.8±44.9) ng·mL-1·h-1,respectively.Conclusion:The method is simple,rapid and sensitive.The results indicated that the two preparations are bioequivalent.
Publication Year: 2013
Publication Date: 2013-01-01
Language: en
Type: article
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