DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR ESTIMATION OF RUFINAMIDE IN BULK AND ITS PHARMACEUTICAL DOSAGE FORM
Journal Title: Int J of Preclin & Pharm Res - Year 2012, Vol 2, Issue 1
Abstract
ABSTRACT A rapid and precise reverse phase high performance liquid chromatographic method has been developed for the validated of Rufinamide, in its pure form as well as in tablet dosage form. Chromatography was carried out on a Symmetry C18 (4.6 x 150mm, 5 m) column using a mixture of, Methanol and Water (50:50 v/v) as the mobile phase at a flow rate of 1 mL/min, the detection was carried out at 220nm. The retention time of the drug was 5.20±0.02 min. The method produced linear responses in the concentration range of 10-60 mg/ml of Rufinamide. The method precision for the determination of assay was below 2.0%RSD. The method is useful in the quality control of Bulk and pharmaceutical formulations. Key words: Rufinamide, RP-HPLC, Validation.
Authors and Affiliations
S. Muneer * , C. Jose Gnana Babu , Ruksana Hakeem , K. Sai Sumanth
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