Extractive spectrophotometric method for determination of rufinamide in bulk and its pharmaceutical dosage form

Abstract

A new economic, industrially acceptable and readily adaptable method has been developed following a complexation (acid-dye method) between antiepileptic drugs and Bromocresol green (BCG) dye and validated for determination of this drug in bulk and its pharmaceutical dosage form. Drug used during analysis i.e. Rufinamide was reacted with BCG in presence of hydrochloric acid buffer pH 1.2. The colored complex formed was extracted with chloroform and the absorbance of the solutions were noted which followed a beer’s law in concentration range of 10-50 μg/ml for Drug-BCG complex with correlation coefficient close to 0.991. The method was validated as per ICH guideline for accuracy, precision, limit of detection and limit of quantification. The developed Spectrophotometric method has the advantages of speed, simplicity, sensitivity and more affordable instrumentation and could find application as a rapid and sensitive analytical method for Rufinamide.