STABILITY INDICATING RP HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF DALFAMPRIDINE IN ITS BULK AND FORMULATION

A simple and selective LC method is described for the determination of DALFAMPRIDINE tablet dosage forms. Chromatographic separation was achieved on a c18 column using mobile phase consisting of a mixture of MixedPhosphate buffer (KH2PO4+K2HPO4) pH:3.5 Acetonitrile (30:70v/v/v), with detection of 244 nm. Linearity was observed in the range 35-105 µg /ml for DALFAMPRIDINE (r2 =0.998) for drugs estimated by the proposed methods was in good agreement with the label claim. Several analytical procedures have been proposed for the quantitative estimation of DALFAMPRIDINE separately and in combination with other drugs.   To my knowledge simple, rapid analytical method for determination of DALFAMPRIDINE has not been reported so far. So attempt was taken to develop and validate a reversed-phase high performance liquid chromatographic method for the quality control of DALFAMPRIDINE in pharmaceutical preparations with lower solvent consumption along with the short analytical run time that leads to an environmentally friendly chromatographic procedure and will allow the analysis of a large number of samples in a short period of time.                

Keywords: Dalfampridine, RP‐HPLC, Method development, Validation