S. Muneer*, B. Mohammed Ishaq, H. Ruksana, Dr. Hindustan Abdul Ahad
Department of Pharmaceutical Analysis, Balaji College of Pharmacy, Anantapur-515001, A. P, India
A B S T R A C T
A simple, accurate and precise Zero order spectroscopy method was developed and validated for the estimation of Rufinamidein bulk and pharmaceutical dosage forms. Dimethyl sulfoxide and distilled water was used as a diluent to dissolve rufinamide. The drug mixture was sonicated for 5 mins for the enhanced solubility. The maximum absorption was found to be at 262.0 nm, which was selected for the further analysis of rufinamidein bulk and its tablet dosage forms. The proposed method was validated according to ICH guidelines. The method showed high sensitivity with linearity range from 100 to 600 μg/mL (r2=0.999). The limit of detection and limit of quantitation for estimation of rufinamide was found to be 3.44 µg/ml and 10.45 µg/ml, respectively. Recovery of rufinamide was found to be in the range of 99.09% – 100.89 %.The reports expressed that the proposed method was found to be simple, precise, accurate and rapid for the estimation of rufinamidein bulk and tablet dosage form using UV spectroscopy.
Keywords: Rufinamide, Dimethyl Sulfoxide, Distilled Water, UV Spectroscopy, ICH Guidelines.