Abstract

A newly developed analytical method was conducted for the determination of Ketotifen fumarate (KTF) in pharmaceuticals drugs via quenching of continuous fluorescence of 9(10H)-Acridone (ACD). The method was applied using flow injection system of a new homemade ISNAG fluorimeter with fluorescence measurements at ± 90◦ via 2×4 solar cell. The calibration graph was linear in the range of 1-45 mmol/L, with correlation coefficient r = 0.9762 and the limit of detection 29.785 µg/sample from the stepwise dilution for the minimum concentration in the linear dynamic ranged of the calibration graph. The method was successfully applied to the determination of Ketotifen fumarate in two different pharmaceutical drugs. A comparison was made between the newly developed method analysis and the classical method using the standard addition method via the use of individual and paired t-test and F-test. It was noticed that there was no significant difference between the two methods at 95 % confidence level.

Highlights

  • Ketotifen Fumarate (KTF) is an antihistaminic drug which has the nomenclature 4-(1-Methylpiperidin-4-ylidene)-4,9-dihydro-10H-benzo[4,5] cyclohepta[1,2-b] thiophen- 10-one hydrogen (E)-butenedioate (Fig. 1) with an empirical formula of C19H19NOS,C4H4O4, and it is a white or brownish-yellow, fine, crystalline powder.It is sparingly soluble in water, slightly soluble in methanol, very slightly soluble in acetonitrile [1].The main biochemical and pharmacological activities of ketotifen fumarate are H1 receptor antagonism, phosphodiesterase inhibition and inhibition of calcium flux in smooth muscle preparations

  • Many analytical methods have been reported for the determination of KTF in pure form and pharmaceutical preparations, which includes spectrophotometric methods

  • A homemade ISNAG fluorimeter was used with 4-channels peristaltic pump (Ismatec, Switzerland) and Six-port medium pressure injection valve (I D E X corporation, USA) with sample loop

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Summary

Introduction

Ketotifen Fumarate (KTF) is an antihistaminic drug which has the nomenclature 4-(1-Methylpiperidin-4-ylidene)-4,9-dihydro-10H-benzo[4,5] cyclohepta[1,2-b] thiophen- 10-one hydrogen (E)-butenedioate (Fig. 1) with an empirical formula of C19H19NOS,C4H4O4, and it is a white or brownish-yellow, fine, crystalline powder.It is sparingly soluble in water, slightly soluble in methanol, very slightly soluble in acetonitrile [1].The main biochemical and pharmacological activities of ketotifen fumarate are H1 receptor antagonism, phosphodiesterase inhibition and inhibition of calcium flux in smooth muscle preparations. Benzo[4,5] cyclohepta[1,2-b] thiophen- 10-one hydrogen (E)-butenedioate (Fig. 1) with an empirical formula of C19H19NOS,C4H4O4, and it is a white or brownish-yellow, fine, crystalline powder. It is sparingly soluble in water, slightly soluble in methanol, very slightly soluble in acetonitrile [1]. The main biochemical and pharmacological activities of ketotifen fumarate are H1 receptor antagonism, phosphodiesterase inhibition and inhibition of calcium flux in smooth muscle preparations. All these actions are suited to prevent the development of asthmatic conditions [2]. Many analytical methods have been reported for the determination of KTF in pure form and pharmaceutical preparations, which includes spectrophotometric methods [3,4,5], chemiluminescence [6, 7], electrochemical [8,9,10], electrochemilu-minescence [11, 12], chromatographic [13, 14], and flow injection analysis (FIA) methods [15,16,17].

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