Stability-Indicating Micelle-Enhanced Spectrofluorimetric Method For Determination of Tamsulosin Hydrochloride In Dosage Forms.

Ibrahim Habib,Mona Elsayed Elshahed

doi:10.24297/jac.v11i2.6692

Abstract

A rapid, simple and highly sensitive spectrofluorimetric method is developed for the determination of Tamsulosin hydrochloride (Tams.HCl) in pharmaceutical formulations. The proposed method is based on investigation of the fluorescence spectral behavior of Tams.HCl in a sodium dodecyl sulphate (SDS) micellar system. In aqueous solution of Tris buffer of pH 7±0.2, SDS causes marked enhancement in the fluorescence intensity of Tams.HCl (about +110%). The fluorescence intensity is measured at 328 nm after excitation at 280 nm and the fluorescence-concentration plots are rectilinear over the range 0.1-1.2 µg ml-1, with lower detection limit of 0.027 µg ml-1 and quantification limit of 0.09 µg ml-1. The method is successfully applied to the analysis of the studied drug in its commercial capsules, and the results are in good agreement with those obtained with the official method. The application of the proposed method is extended to stability studies of Tamsulosin hydrochloride after exposure to different forced degradation conditions, such as acidic, alkaline and oxidative conditions, according to ICH guidelines.

Highlights

Tamsulosin 5-[(2R)-2-[[2-(2-Ethoxyphenoxy)eth yl]amino]propyl]-2- ethoxybenzene-sulfonamide [1] (Fig. 1)
Se veral chromatographic methods were described for determination of Tamsulosin, such as highperformance liquid chromatography (HPLC) with UV detection [3, 6,7,8,9], fluorescence detection [10], mass spectrometric detection [11,12,13,14,15], and capillary electrophoresis [16]
The results of stability studies were calculated from fluorescence measurement of Tams.HCl in both aqueous and micellar media and they were so close in both conditions

Summary

Introduction

Tamsulosin 5-[(2R)-2-[[2-(2-Ethoxyphenoxy)eth yl]amino]propyl]-2- ethoxybenzene-sulfonamide [1] (Fig. 1). Tamsulosin is an alpha1- adrenoceptor blocker; it is reported to be more selective for the alpha 1A-adrenoceptor subtype. It is used in benign prostatic hyperplasia to relief symptoms of urinary obstruction. Several analytical procedures describing the determination of Tamsulosin have been published; these methods include non-aqueous titration [3], voltammetry [4] and spectrophotometry [5]. Se veral chromatographic methods were described for determination of Tamsulosin, such as highperformance liquid chromatography (HPLC) with UV detection [3, 6,7,8,9] , fluorescence detection [10] , mass spectrometric detection [11,12,13,14,15] , and capillary electrophoresis [16]

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Conclusion