Dionex Application Note 238: Determination of sulfate and sulfamate in topiramate

Dionex announces a new method for determination of sulfate and sulfamate in a pharmaceutical preparation using ion chromatography. Application Note 238: ‘Determination of sulfate and sulfamate in topiramate using a reagent-free ion chromatography system’, describes a method that uses a reagent-free ion chromatography system with the IonPac AS11 column and suppressed conductivity detection for the determination of sulfate and sulfamate in Topiramate.

Topiramate is a second-generation anti-epileptic drug used for the treatment of seizures and migraines. At elevated temperatures and humidity, the active pharmaceutical ingredient can degrade to produce organic degradation products insoluble polymeric products, and the inorganic anions sulfamate and sulfate.

Determination of sulfate and sulfamate (the inorganic degradation products) can be used to monitor and confirm topiramate degradation.

The method described in AN 238 demonstrates good linearity, precision and accuracy for determining these inorganic degradation by-products.

This method also provides a simpler approach than the current and proposed USP methods for analysis of this drug product.