Abstract
A new patented route for the synthesis and analysis of Topiramate has been developed. In order to determine the impurities in the active pharmaceutical ingredient, three HPLC methods: an isocratic elution method with RI detection, a gradient elution method with diode-array detection, an ion-chromatographic method with inverse UV and/or RI detection and an HPLC-MS method were applied. Inverse RI proved to be a very powerful and sensitive technique. It is demonstrated that MS detection can replace both RI and UV detection, only one method being required for non ionic impurities. The methods were validated according to the ICH Q2A and Q2B guidelines. The full set of validation criteria laid out by the international guidelines were satisfied. With these new validated methods, the pharmaceutical analysis requirements were met; the methods can be successfully applied for product evaluation and stability testing.
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