Abstract

DEVELOPMENT & VALIDATION OF STABILITY INDICATING RP- HPLC METHOD FOR QUANTITATIVE ESTIMATION OF DIMETHYFUMARATE AND ITS IMPURITIES IN DRUG SUBSTANCE AS PER ICH GUIDELINES

Venkateswara Reddy Billa*, Prof. Anuradha Vejendla, Prof. Ramachandran Dittakavi and Naveen Reddy Seelam

ABSTRACT

The analysis of improved RP-HPLC method for the separation and quantification of Dimethyl Fumarate and its impurities are described. Samples are analysed by means of reverse phase (RP-HPLC) using an Kromasil C18, 250 x 4.6 mm, 5μm and the mobile phase consists of pH 2.40 buffer: Acetonitrile (65:35 %v/v). The flow rate is 0.7 ml/min. The column temperature was maintained at 30°C and sample temperature was maintained at 10°C and wavelength fixed at 220nm UV-detection. It is found that the method of RP-HPLC with UV-detection system for the analysis of Dimethyl Fumarate impurities are straight forward and applied in qualitative and quantitative analysis. The developed LC method was validated with respect to specificity, precision, linearity, ruggedness and robustness. Validation study compared as per ICH guideline.

Keywords: Dimethyl Fumarate, estimation of related substances, liquid chromatography.