A VALIDATED TLC- DENSITOMETRY FOR THE SIMULTANEOUS DETERMINATION OF TAMSULOSIN AND DUTASTERIDE IN THEIR COMBINED PHARMACEUTICAL FORMULATION.

Document Type : Original Article

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Department of Analytical chemistry, Faculty of Pharmacy, October 6 University, 6 October City, Giza, Egypt.

Abstract

A TLC densitometric method was developed and validated for simultaneous determination of dutasteride and tamsulosin in their challenging combined pharmaceutical formulation, where the separation process was achieved using a mobile phase composed of ethyl acetate: methanol: hexane: ammonia (90: 5: 3: 2 by volume) on pre-coated silica gel (60 GF254) plates, densitometric quantification was performed at 270 nm for both drugs. TAMS and DUTA were resolved with Rf values of 0.57± 0.01 and 0.72 ± 0.01 with a mean percentage recovery of 100.51 ± 0.659 and 100.81 ± 0.743, respectively. Method validation was performed following the International Conference on Harmonization (ICH) guidelines and was victoriously applied for simultaneous determination of  tamsulosin HCl and dutasteride in their pharmaceutical formulation. The acquired results of the  Proposed method were statistically compared with those acquired by the reported methods, demonstrating no significant difference. Therefore, the proposed method has the potential for being fast, simple, economic, and selective for sustainable analysis of the cited drugs.

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Al-Azhar Journal of Pharmaceutical Sciences
Volume 64, Issue 2 - Serial Number 2
September and October 2021
Pages 93-108

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