Greenness Assessment UV-Stability Spectrophotometric Methods for Determination of Dalfampridine in the Presence of its Oxidative Derivative

Abstract

This study describes three spectrophotometric techniques that were developed and verified for the reliable identification of dalfampridine (DFP) in the presence of its oxidative derivative, namely (Derivative ratio 1DD, Ratio subtraction RD, and Bivariate BI); calibration graphs were established in the range of (1–14 ug/mL) with good correlation coefficients. The established techniques have been effectively used to analyze Dalfampridine (DFP) in its pharmaceutical dose form. The procedures were verified in accordance with ICH requirements, and accuracy, precision, and repeatability were determined to be satisfactory. The degradation pathway was confirmed using TLC, IR, 1H NMR and mass spectrometry. In addition to Analytical Greenness metrics (AGREE) method and Analytical Eco-Scale tools were applied for DFP with greenness assessment.