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Abstract

Objective: The current study aimed to develop and validate New-UPLC assay and dissolution methods for determination of Dimethyl Fumarate in their capsule dosage form. Method: Chromatographic system was performed on the Waters Acquity BEH-C8 (50 mm× 2.1 mm) 1.7µm using isocratic systems Water : Acetonitrile: Phosphoric acid 85% (70:30:1 v/v) at flow rate of 0.5 mL/min, injection volume 0.8 µL, UV detection at 210 nm, Column Oven Temperature25 ºC and Autosampler Temperature 15 ºC. 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. Conclusion:New, simple, accurate, economical and stability-indicating RP-UPLC method was developed and validated for estimation of Dimethyl Fumarate in their capsule dosage form.