Development and Validation of Stability Indicating HPLC Method For Estimation of Diroximel Fumarate

Abstract

Diroximel fumarate (DRF) is a new drug treatment for multiple sclerosis. A rapid, selective and sensitive high-performance liquid chromatography method was developed for Diroximel fumarate. The column used Nucleosil C18 column (250 x 4.6mm, 5μm), mobile phase was a water and ACN in the ratio of (65:35 v/v.) The flow rate kept at 1.0 mL/min. Detector wavelength was monitored at 210 nm, and the injection volume was 20μL and run time was kept 13 min. The developed method was validated in terms of linearity, range, accuracy, precision, repeatability and specificity, robustness, LOD and LOQ as per ICHQ2(R1). The method had excellent linearity in the concentration ranges of (2 to 12 μg/mL) having LOD 0.1 μg/mL and LOQ 0.5 μg/mL with regression coefficients of 0.9998. The recovery ratios were in the range of 98.0%–100.1%. The precision was evaluated by studying intermediate precision and repeatability. precision was performed in a similar way another day. The %RSD values for repeatability were 0.4% and intermediate precision were 1.1% respectively. Diroximel Fumarate (DRF) was subjected to the forced degradation studies showed acidic degradation (19.58%), alkaline degradation (22.31%), Oxidative degradation (27.58%), but found stable in thermal and photolytic degradation condition. The developed method can be used to monitor the quality control of the drug and it can be applied to stability study