METHOD DEVELOPMENT AND VALIDATION OF NOVEL ANALYTICAL METHODS FOR TOPIRAMATE IN BULK AND PHARMACEUTICAL FORMULATIONS USING UPLC TECHNIQUE
A simple and selective UPLC method is described for the determination of Topiramate. Chromatographic separation was achieved on a Cortecs Phenyl (100 x 2.0mm) 1.5µm C18 column using mobile phase consisting of a mixture of 60 volumes of Ammonium phosphate Buffer, 40 volumes of Methanol with detection of 260 nm. Linearity was observed in the range 50-150 µg /ml for Topiramate (r2 =0.999) estimated by the proposed method was in good agreement with the label claim. The proposed methods were validated. The accuracy of the methods was assessed by recovery studies at three different levels. Recovery experiments indicated the absence of interference from commonly encountered pharmaceutical additives. The method was found to be precise as indicated by the repeatability analysis, showing %RSD less than 2. All statistical data proves validity of the methods and can be used for routine analysis of pharmaceutical dosage form.