Development and Validation of RP-HPLC and UV Spectroscopy Method for the Determination of Diroximel Fumarate in Bulk Drug and Pharmaceutical Dosage Form

Two new, simple, specific, precise and accurate UV-spectrophotometric and one reverse phase high performance liquid chromatography methods have been developed for the estimation of Diroximel Fumarate in Pharmaceutical dosage form. First UV-spectrophotometric methods show absorption maxima at 253nm for the Diroximel Fumarate. Percentage mean recovery obtained was 100.00%; coefficient of variance was found to be less than 2% and linearity coefficient was 0.9998. Linear response obtained for Diroximel Fumarate was in the concentration range of 0.5-2.5g/ml. The limit of detection and limit of quantification for Diroximel was found to be 0.049g/ml and 0.149g/ml, respectively, and Second RP-HPLC method, chromatography analysis is carried out using Methanol: 10mm of KH2PO4 buffer solution (pH 3.1) (70:30%, v/v) as the mobile phase and C18 Waters (4.6mm x 150mm), 5.0μ column as stationery phase with detection wavelength of 272nm linearity was obtained in the concentration range of 5-25μg/ml for Diroximel Fumarate. Both UV-spectrophotometric and reverse phase high performance liquid chromatography methods were statistically validated according to I.C.H. Guidelines.