Simple and validated method for estimation of amlodipine by LC-MS (ESI) using Healthy Indian Human Volunteers: And evaluation of pharmacokinetic parameters

Abstract

A simple and validated liquid chromatographic-mass spectrometric method (LC-MS) for amlodipine in human plasma was quantified using LC-MS (ESI). Chromatography was performed on a C18 analytical column, the mobile phase used was Acetonitrile-10mM Ammonium acetate in the ratio of 90:10%v/v and the retention times were 0.829 and 1.281 min for azithromycin (Internal standard) and amlodipine respectively. The ionization was optimized using ESI (+) and enhanced selectivity was achieved. The method is validated as per FDA guidelines. The analyte was shown to be stable over the timescale of the whole procedure. The pharmacokinetic parameters such as peak plasma concentration (Cmax), Time to peak Concentration (tmax), Area under the plasma concentration-time curve (AUC0-t & AUC0-∞), elimination rate constant (Keli), Elimination half-life (t1/2) were calculated. Log transferred values were compared by Analysis of Variance (ANOVA) followed by classical 90% confidence interval for Cmax AUC0-t· and AUC0-∞ and was found to be within the range. These results indicated that the Test and Reference formulation is bioequivalent. © 2010 Moses PF, et al.