METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD DIROXIMEL FUMARATE IN BULK DRUG AND IT'S DOSAGE FORM

A Diroximel Fumarate is clinically used in combination in the treatment of anti-inflammatory agent. The present work deals with the RP-HPLC methods for Diroximel Fumarate  in pharmaceutical formulation. attempts were made to develop rp-hplc method for estimation of diroximel fumarate  bulk drug and formulation For the rp   hplc method, agilent  (s.k) gradient system uv detector and C18 column with 250mm x4.6 mm i.d and 5μm particle size methanol: water (0.05% Formic Acid) (90:10v/v) ph 3 was used as the mobile phase for the method. the detection wavelength was 255 nm and flow rate was 1.0 ml/min. in the developed method, the retention time of diroximel fumarate  were found to be 3.78 min. the developed method was validated according to the ICH guidelines. The linearity, precision, range, robustness was within the limits as specified by the ICH guidelines. Hence the method was found to be simple, accurate, precise, economic and reproducible. So, it is worthwhile that, the proposed methods can be successfully utilized for the routine quality control analysis diroximel fumarate  in bulk drug as well as in formulations..

Keywords: Diroximel Fumarate, RP-HPLC, Accuracy.