Development and Validation of RP-HPLC Method for Dissolution Drug Release of Dimethyl Fumarate Delayed Release Capsules

Abstract

The objective of the current study was to develop and validate a short, economical, accurate, precise RP-HPLC method for drug release profiles of dimethyl fumarate delayed release capsules with avoiding acidic media degradation while performing the dissolution testing. The RP-HPLC method was developed by using liquid chromatography (waters 2695 with PDA detector) with XBridge C18 column using isocratic elution with a flow rate of 1.2 mL/min and detector wavelength of 223 nm. The mobile phase consists of 0.1% of ortho-phosphoric acid in water: acetonitrile (50:50% v/v) and runtime of 4 mins. In-vitro drug release study was designed by using USP type II apparatus with 0.1N HCl for 120 minutes followed by drug release profiles of 10, 20, 30 and 45 minutes with phosphate buffer pH: 6.8. The developed method was validated as per ICH guidelines. Good linearity and accuracy were achieved in the range of 0.1-120% of the nominal sample concentration. The similarity factor of (f2) 80 ≥ 50% indicates similarity between two dissolution profiles with less variation in drug release and the predicted method was accurate and precise. To improve the quantification of drug release, which is unstable in physiological dissolution medium of 0.1N HCl, was achieved by addition of suitable diluent in sample preparation. The intended drug release profiles method published here will support the pharmaceutical industries for quick quantitation of DMF in formulation development, routine analysis and stability studies of dimethyl fumarate drug product without compromise in quality attributes.