Loading…
Amlodipine bioequivalence study: quantification by liquid chromatography coupled to tandem mass spectrometry
Objective—To assess the bioequivalence of two amlodipine tablet formulations (Amlodipine® 5 mg tablet from Merck S.A. Indústrias Químicas, Brazil as test formulation and Norvasc® 5 mg tablet from Laboratórios Pfizer Ltd., Brazil as reference formulation) in 24 healthy volunteers of both sexes. Metho...
Saved in:
Published in: | Biopharmaceutics & drug disposition 2001-12, Vol.22 (9), p.383-390 |
---|---|
Main Authors: | , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Citations: | Items that this one cites Items that cite this one |
Online Access: | Get full text |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
Summary: | Objective—To assess the bioequivalence of two amlodipine tablet formulations (Amlodipine® 5 mg tablet from Merck S.A. Indústrias Químicas, Brazil as test formulation and Norvasc® 5 mg tablet from Laboratórios Pfizer Ltd., Brazil as reference formulation) in 24 healthy volunteers of both sexes.
Methods—The study was conducted using an open, randomized two‐period crossover design with a 4‐week washout interval. Plasma samples were obtained over a 144 h period. Plasma amlodipine concentrations were analyzed by combined liquid chromatography coupled to tandem mass spectrometry (LC‐MS‐MS) with positive ion electrospray ionization using multiple reaction monitoring (MRM). From the amlodipine plasma concentration vs time curves, the following pharmacokinetic parameters were obtained: AUClast, AUC0–inf and Cmax. The statistical interval proposed was 80–125% according to the US Food and Drug Administration Agency.
Results—The limit of quantification was 0.1 ng/ml for plasma amlodipine analysis. The geometric mean and the 90% confidence interval (CI) test/reference ratios were 101.2 (92.9–110.2%) for AUClast, 99.6 (91.5–108.4%) for AUC0–inf and 98.5 (89.0–109.1%) for Cmax.
Conclusion—Since the 90% CI for AUClast, AUC0–inf and Cmax ratios were within in the 80–125% interval proposed by the US FDA, it was concluded that Amlodipine® 5 mg tablet (test formulation) was bioequivalent to Norvasc® 5 mg tablet, in terms of both rate and extent of absorption. Copyright © 2001 John Wiley & Sons, Ltd. |
---|---|
ISSN: | 0142-2782 1099-081X |
DOI: | 10.1002/bdd.282 |