ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF DALFAMPRIDINE: A REVIEW

Sandeep K.*, Suresha D. N. and Naveen Kumar G. S.

ABSTRACT

Analytical method development and validation are the continuous and inter- dependent task associated with the research and development, quality control and quality assurance departments. Analytical procedures play a critical role in equivalence and risk assessment, management. It helps in establishment of product specific acceptance criteria and stability of results. Validation should demonstrate that the analytical procedure is suitable for its intended purpose. Design of experiment is a powerful tool method characterization and validation. Analytical professionals should be comfortable to use it to characterize and optimize the analytical method. An effective analytical method development and its validation can provide significant improvements in precision and a reduction in bias errors. It can further help to avoid costly and time-consuming exercises. Literature survey reveals that few HPLC & HPTLC methods have been reported for the determination of Dalfampridine. The published methods were validated for various parameters as per ICH guidelines, statistical analysis provided that the published methods were reproducible and selective for the estimation of the Dalfampridine in pure and pharmaceutical dosage forms.

Keywords: Dalfampridine, Validation, method development, ICH guidelines.