VALIDATED FOR THE ESTIMATION OF AMLODIPINE IN HUMAN PLASMA OVER
Journal Title: Indo American Journal of Pharmaceutical Research - Year 2011, Vol 1, Issue 5
Abstract
The present study aims to develop the bio-analytical method for the estimation of amlodipine in human plasma and evaluate the pharmacokinetic variables after a single oral dose in eight healthy male human volunteers in a two way, two period, and complete crossover design. For the estimation of the drugs present in the biological fluid, LC-MS/MS method is considered to be more suitable. 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. 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® 10 mg tablet (test formulation) was bioequivalent to Norvasc® 10 mg tablet, in terms of both rate and extent of absorption.
Authors and Affiliations
Rajesh Manyam, Karuna Prasad, P. Y. Naidu, Arghya Acharjee, Subal debnath
Keywords
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