Abstract

The present study describes two simple, rapid, selective, and cost-effective spectrophotometric methods for the determination of an antiallergic drug, fexofenadine hydrochloride (FFH), in bulk drug, tablets, and in spiked human urine. The first method (method A) is based on the formation of yellow-colored ion-pair complex between FFH and alizarin red S (AZS) in acid medium which was extracted into dichloromethane, and the absorbance was measured at 440 nm. The second method (method B) is based on the breaking of the yellow FFH–AZS ion-pair complex in alkaline medium followed by the measurement of the violet-colored free dye at 590 nm. Under the optimized conditions, Beer’s law is obeyed over the concentration ranges of 0.4–12.0 and 0.2–3.5 μg FFH for method A and method B, respectively, and the corresponding molar absorptivity values are 3.80 × 104and 1.61 × 105 L . The Sandell’s sensitivity, detection, and quantification limits are also reported. The proposed methods were successfully applied to the determination of FFH in pure drug and commercial tablets. The accuracy and reliability of the proposed methods were further established by recovery studies via standard addition technique.

Highlights

  • Fexofenadine hydrochloride (FFH), chemically known as (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-a,a-dimethyl benzene acetic acid hydrochloride [1], is an active metabolite of terfenadine and is a second-generation histamine H1-receptor antagonist in piperidine-class drugs

  • The reaction of fexofenadine hydrochloride (FFH) with alizarin red S (AZS) in an acidic medium to form a yellow ion-pair complex was investigated, and this complex was extracted into dichloromethane

  • In method B, this FFH– AZS ion-pair complex was treated with ethanolic KOH to yield a chromogen, the dissociated form of AZS, which exhibited bathochromic shift to maximum absorbance of 590 nm (Figure 1)

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Summary

Introduction

Fexofenadine hydrochloride (FFH), chemically known as (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-a,a-dimethyl benzene acetic acid hydrochloride [1], is an active metabolite of terfenadine and is a second-generation histamine H1-receptor antagonist in piperidine-class drugs. Apart from this, quite a few extractive spectrophotometric methods based on ion-pair formation reaction of FFH with dyes have been reported. Alaa et al [24], devised extractive spectrophotometric methods for the estimation of FFH based on ion-pair reaction employing some acidic dyes namely, bromothymol blue, bromophenol blue, bromocresol green, and bromocresol purple. This study was directed to develop two accurate, selective, precise, and inexpensive procedures for the determination of FFH in pharmaceuticals based on ion-pair complex formation using AZS as a reagent

Experimental
Recommended Procedures
Methodology
Results and Discussion
Method B
Conclusions

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