Abstract

There are some shortages for those methods described in literature for the simultaneous determination of quetiapine and its metabolite quetiapine fumarate in human plasma. So, the purpose of experiment was to develop and validate the analytical method for simultaneous determination of Quetiapine and its metabolite, Quetiapine fumarate and to determine the concentration level of Quetiapine and Quetiapine fumarate in human plasma samples and their pharmacokinetics evaluation in human volunteers after single dosing of two formulations of Quetiapine 25mg in fasting conditions. Sample preparation process was accomplished by solid phase extraction with methanol. The dried and reconstituted solution was subjected to chromatography on Atlantis dC18 column (100mm×3.0 mm,3μm) at 40±5◦C using a mobile phase mixture (acetonitrile–methanol-ammonium acetate). The sample was injected at a flow rate of 0.4ml/ min. and the eluent detected by MS/MS system by optimizing m/z ratio. The total precision (% Coefficient of variation) for the Quetiapine and Quetiapine fumarate ranged from 1.1 % to 5.7 % respectively and within batch accuracy ranged from 91.5 % to 109.6% and 96.86% to 102.77 % respectively. The mean recovery of Quetiapine and Quetiapine fumarate were found to be 72.96% & 69.3% respectively. The concentration data was pharmacokinetically evaluated using ANOVA (Analysis of variance) and evaluation of bioequivalence was based on pharmacokinetic parameters. Both objectives of the study were successfully met. From the result of safety evaluation, it was concluded that both the test and reference formulations were well tolerated. © 2018 iGlobal Research and Publishing Foundation. All rights reserved.

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