Abstract

Novel spectrophotometric techniques for determination of trazodone hydrochloride in bulk powder and pharmaceutical formulation

Author(s): A.E.El-Gindy, M.Farouk, O.Abd El-Aziz, E.A.Abdullah

Three simple novel spectrophotometric methods were established for the analysis of Trazodone (TRZ). The proposed methods are stability indicating for determination of Trazodone in presence of its degradation products, obtained by stressing Trazodone by alkali and hydrogen peroxide in presence of heat, respectively. The adopted zero-crossing derivative, derivative ratio and pH-induced difference spectrophotometric techniques were proved to be sensitive and accurate, where the accuracy of the assay was evaluated using the standard deviation coefficient of variation which were found to be within the acceptable limit of 2% and were specifically 0.761&0.598%,0.389&0.341%and 0.738&0.406%for intradayand interday samples, respectively. All the proposed methods were validated according to the International Conference on Harmonization (ICH) guidelines reference and successfully applied for determination of Trazodone Hydrochloride in pure form, in laboratory prepared mixtures and in pharmaceutical formulation. The obtained results were statistically compared to the reference method of analysis for Trazodone Hydrochloride and no significant differences were found.