SPECTROPHOTOMETRIC DETERMINATION OF ACOTIAMIDE HYDROCHLORIDE TRIHYDRATE IN THE PRESENCE OF ITS OXIDATIVE DEGRADATION PRODUCT BY DIFFERENT RATIO SPECTRA MANIPULATING METHODS

Sherif Ramzy

Abstract


Back ground: Acotiamide hydrochloride trihydrate is a novel gastroprokinetic drug which has been recently approved for the treatment of patients with functional dyspepsia. Objective: Analysis of acotiamide hydrochloride trihydrate in the presence of its oxidative degradation product by simple spectrophotometric methods. Methods: The absorption spectra of acotiamide hydrochloride trihydrate (1─15 µg/mL) were divided by spectrum of the degradation product (11 µg/mL) to get the ratio spectra. Results: Ratio difference, first derivative of the ratio spectra, and mean centering methods have been developed for manipulating the ratio spectra of acotiamide hydrochloride trihydrate to remove any interference from its degradation product. Conclusion: The proposed methods have been successfully applied and validated to the analysis of the drug in its pure or new pharmaceutical dosage form in the presence of its oxidative degradation product. Highlights: This study presents the first reported spectrophotometric methods for determination of acotiamide hydrochloride trihydrate in the presence of its oxidative degradation product.



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