New Kinetic Spectrophotometric Method for Determination of Fexofenadine Hydrochloride in Pharmaceutical Formulations

Safwan Ashour,Mouhammed Khateeb

doi:10.1155/2014/308087

Abstract

A simple and sensitive kinetic spectrophotometric method was developed for the determination of fexofenadine hydrochloride in bulk and pharmaceutical preparations. The method is based on a kinetic investigation of the oxidation reaction of fexofenadine using alkaline potassium permanganate as an oxidizing agent at room temperature. The reaction is followed spectrophotometrically by measuring the increase of absorbance owing to the formation of manganate ion at 610 nm. The initial rate and fixed time (at 15 min) methods are utilized for construction of calibration graphs. All the reaction conditions for the proposed method have been studied. The linearity range was found to be 2.5–50.0 μg mL−1 with detection limit of 0.055 μg mL−1 for both initial rate and fixed time methods. The proposed method was applied successfully for the determination of fexofenadine in pharmaceutical formulations; the percentage recoveries were 99.98–101.96%. The results obtained were compared statistically with those obtained by the official method and showed no significant differences regarding accuracy and precision.

Highlights

Fexofenadine, (±)-4-[1-hydroxy-4-[4-(hydroxyl diphenylmethyl)-1-piperidinyl]butyl]-alpha, alpha-dimethyl benzene acetic acid, an active metabolite of terfenadine, is a selective histamine H1-receptor antagonist and is clinically effective in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria as a first-line therapeutic agent, such as loratadine and cetirizine [1]
Fexofenadine hydrochloride has been determined in combination with other drugs using HPLC [15,16,17,18,19], HPTLC [20], and spectrophotometry [21,22,23] in combined dosage forms
Some specific advantages that the kinetic methods possess are as follows: simple and fast methods because some experimental steps such as filtration and extraction are avoided prior to absorbance measurements; high selectivity since they involve the measurement of the absorbance as a function of reaction time instead of measuring the concrete absorbance value; other active compounds present in the commercial dosage forms which may not interfere if they are resisting the chemical reaction conditions established for the proposed kinetic method, and colored and/or turbid sample background which may not possibly interfere with the determination process [29, 30]

Summary

Introduction

Fexofenadine, (±)-4-[1-hydroxy-4-[4-(hydroxyl diphenylmethyl)-1-piperidinyl]butyl]-alpha, alpha-dimethyl benzene acetic acid, an active metabolite of terfenadine, is a selective histamine H1-receptor antagonist and is clinically effective in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria as a first-line therapeutic agent, such as loratadine and cetirizine [1]. Several methods for the determination of fexofenadine hydrochloride in pharmaceutical formulations and biological fluids have been reported including HPLC [2,3,4,5], spectrophotometry [5,6,7,8,9], extractive spectrophotometry and conductometry [10], spectrofluorometry [11], potentiometry [12], and capillary electrophoresis [13, 14]. The literature is still poor in analytical assay methods based on kinetics for the determination of fexofenadine in dosage forms. Some specific advantages that the kinetic methods possess are as follows: simple and fast methods because some experimental steps such as filtration and extraction are avoided prior to absorbance measurements; high selectivity since they involve the measurement of the absorbance as a function of reaction time instead of measuring the concrete absorbance value; other active compounds present in the commercial dosage forms which may not interfere if they are resisting the chemical reaction conditions established for the proposed kinetic method, and colored and/or turbid sample background which may not possibly interfere with the determination process [29, 30]

Methods

Results

Conclusion