Abstract

Development and validation of spectroscopic methods for the estimation of Dalfampridine in bulk and in tablet formulation

Author(s): Vivekkumar K.Redasani, Gazala L.Shaikh, Sanjay J.Surana

Four simple, precise and cost effective spectrophotometric methods have been developed for the estimation of Dalfampridine in bulk and its tablet formulation. Dalfampridine was estimated at 262 nm in UV-spectroscopy (Method A), 274.5 nm in first order derivative spectroscopy (Method B), scanned at 254.2 - 269.0 nm in area under curve for zero order derivative spectroscopy (Method C) and at 267.2 - 284.2 nm in area under curve for first order derivative spectroscopy (Method D). The drug follows Beer- LambertÂ’s law in the concentration range of 2.0 -7.0 ìg/ml in all themethods. All the methods were validated by following the analytical performance parameters suggested by International Conference onHarmonization (ICH) guidelines.All validation parameterswere within the acceptable range. The developed methods were successfully applied to estimate the amount of dalfampridine in bulk and in tablet formulation