Abstract

Asensitive and simple spectrophotometric method has been developed for quantitative determination of fluoxetine using bromatometric method. The method is based on the addition of measured excess amount of bromate-bromide mixture to fluoxetine in hydrochloric acid medium. The residual bromine was determined by reacting with a fixed amount ofmethyl orange and absorbance was measured at 505 nm. The amount of bromine reacted corresponds to the amount of fluoxetine. Linear relationship between absorbance and fluoxetine concentration was found and Beer’s law was obeyed in the concentration range of 0.4 - 12 μg·mL–1. The molar absorptivity was found to be 3.8 × 104 L·mol–1·cm–1. The limit of detection and limit of quantification was calculated and found to be 0.32 μg·mL–1 and 1.0 μg·mL–1respectively. The common excipients were investigated for their interferences effect in the assay. The validity of the developed method was checked through recoveries studies and successfully applied to the determination of fluoxetine in bulk powder, pharmaceutical formulations and spiked human plasma samples. The percent recoveries were found to be in the range of 97.0% - 101.0% for pharmaceutical formulations and from 97.0% - 99.0% for spiked human plasma.

Highlights

  • Fluoxetine hydrochloride, (±)-N-methyl-3-Phenyl-3-[(α, α,α-trifluoro-p-tolyl)] propylamine hydrochloride (Figure 1), is an antidepressant drug used for the handling of unipolar mental depression

  • Asensitive and simple spectrophotometric method has been developed for quantitative determination of fluoxetine using bromatometric method

  • The present method deals with the spectrophotometric determination of fluoxetine using bromate-bromide mixture as the oxidimetric reagent

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Summary

Introduction

Fluoxetine hydrochloride, (±)-N-methyl-3-Phenyl-3-[(α, α,α-trifluoro-p-tolyl)] propylamine hydrochloride (Figure 1), is an antidepressant drug used for the handling of unipolar mental depression. Fluoxetine (FLX) is the most widely prescribed selective serotonin reuptake inhibitor antidepressant drug [1]. FXT has been shown to have comparable efficacy to tricyclic antidepressants but with fewer cardiovascular and anticholinergic side effects [2,3]. It is effective in treatment of the obsessive compulsive disorders [4]. Fluoxetine is extensively metabolized by N-demethylation in liver into its active metabolite norfluoxetine [5]. It is well absorbed after oral administration, and it takes 6 - 8 hours to reach the plasma peak

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