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NEW VALIDATED EXTRACTIVE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF RUFINAMIDE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM

P. Jagadeesh, U. Srikanth, M. M. Eswarudu*, P. Srinivasa Babu, Sk. Aneesh,P.S.H. R. Khan, S. Sai Pooja, K. Naga Rani

A simple, precise, selective and affordable spectrphotometric method has been developed for the determination of Rufinamide in its bulk and pharmaceutical dosage form. The method was based on ion-pair complex formation between the drug and anionic dye i.e. Bromothymol blue in acidic medium (pH 2.0-4.0). The coloured complex formed was quantitatively extracted into chloroform and measured wavelength at 416.5 nm. Beer’s law was obeyed in the concentration range of 10-60µg/ml with correlation coefficient (n=6) ≥ 0.997. The stoichiometry of the complexes formed between drug and dye was 1:1 ratio, as determined by job’s method of continuous variation. The association constant (Ka) of the ion-pair complexes formed was evaluated using Benesi–Hildebrand equation. Extraction procedure at various pH was measured and maximum absorbance was shown at pH 4.0. The developed method was validated according to ICH [Q2 (R1)] guidelines. This method has been successfully applied for the assay of drug in pharmaceutical formulations. No interference was observed from pharmaceutical adjuvants. Keywords: Rufinamide, Bromothymol blue, Chloroform, Ion- pair complex, UV- Visible spectrophotometer, Validation.

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