Abstract
Brivaracetam is a racetam derivative of levetiracetam having prominent activity against epilepsy. Objective of the proposed work was to develop and validate a new In-Vitro dissolution methodology for quantitation of % Brivaracetam release fromtablets using HPLC analysis. No official HPLC method has been published yet for the dissolution study of Brivaracetam. All the dissolution parameters have been optimized for quantitation purpose. Initially, 900ml of 0.05M Potassium dihydrogen phosphate buffer (pH 6.4) has taken as a dissolution medium, using a paddle apparatus operated at 75rpm for 45 minutes. Chromatographic analysis has been carried out on C18 column (Inertsil ODS 3V HPLC Column having dimensions of 150 mm × 4.6mm, 5μm), isocratic analysishas been conductedwith mobile phase containing a mixture of 0.1%v/v trifluoroacetic acid in water and acetonitrile (60:40 v/v) at a flow rate of 1.0mL/min with the elution monitored at wavelength of 210 nm and column oven temperature of 30°C. The method was further validated to meet the requirements of regulator. The dissolution method of analysis developed was adequate for its purpose and could be employed for the routine quality control of Brivaracetam tablets.
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