Stability Indicating New-UPLC Method for Determination of Dimethyl Fumarate in their Pure and Capsule Dosage Form

Abstract

Results: This method was validated according to ICH requirements for new methods, which include accuracy, precision, selectivity, robustness, ruggedness, LOD, LOQ, linearity and range. Linear relationships were obtained in the ranges of 5-160 μg/mL with correlation coefficients of 0.9997. The forced degradation studies as acidity, alkalinity, oxidation, heat, and thermal, humidity and photo degradation were performed according to ICH guidelines.