ANALYTICAL AND BIOANALYTICAL METHOD DEVELOPMENT OF MONOMETHYL FUMARATE AND ITS APPLICATION FOR PHARMACOKINETIC STUDY

Abstract

Monomethyl fumarate is the pharmacologically active metabolite of immune modulator dimethyl fumarate. It is used f0r the treatment 0f relapsing f0rms 0f multiple scler0sis, relapsing-remitting disease, and active sec0ndary pr0gressive disease, in adults. The maj0r 0bjective 0f this thesis was t0 devel0p selective and sensitive meth0d f0r HPLC and LCMS analysis 0f MMF, t0 study its pharmac0kinetics in rat plasma. The chr0mat0graphic separati0n was achieved 0n a HYPERSIL GOLD, 50 ×4.6 mm,5u C18 by using a 70:30 (v/v) mixture 0f acet0nitrile and 10mM amm0nium f0rmate as the m0bile phase at a fl0w rate 0f 1 mL/min at wavelength of 265 nm.