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Publication Type : Journal Article
Publisher : Materials Today Proceedings.
Source : Materials Today Proceedings. (2021)
Keywords : Dronedarone impurity, drug impurity, spectrophotometry, UV–Visible, Validation
Campus : Bengaluru
School : School of Engineering
Center : Analytical Chemistry
Department : Chemistry
Year : 2021
Abstract : DND-1 is a process-related impurity associated with the antiarrhythmic drug Dronedarone (DND). The quantification of drug impurities is an important part of the drug development process and there is no estimation technique reported so far for DND-1. In this work, two facile and responsive spectrophotometric methods have been developed for the assaying of DND-1. The proposed methods are then validated as per ICH guidelines for precision and accuracy. The methods were simple, fast, and free from extraction steps. The methods also enjoy trace level limits of detection and quantification and could be used for the routine quality control analysis of DND-1.
Cite this Research Publication : B.L. Bhaskar and S. Anil Kumar, “Development and validation of two spectrophotometric methods for the estimation of Dronedarone impurity molecule:”, Materials Today Proceedings., 2021.