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Determination of sulfamate and sulfate in topiramate tablets according to USP monograph

Official quality control method for the second-generation antiepileptic drug topiramate which also have shown effect against migranes. This analysis was performed according to the United States Pharmacopeia monograph and determines the degradation products sulfamate and sulfate which can be formed during storage in humid environments or at elevated temperatures.

Without suppressor, the p-hydroxybenzoic acid eluent used in this application, resulted in negative peaks that were difficult to quantify accurately. Employing the Xenoic® XAMS membrane suppressor with the Xenoic® ASUREX automatic regenerator enhanced detectability, reduced noise and allowed for easier integration.

Sulfamate and Sulfate in Topiramate tablet

Analysis of limit of sulfamate and sulfate in Topiramate tablets according to the specific tests defined in USP 41 (monograph 2018:4145). Ion chromatography separation on a USP class L47 column (Hamilton PRP-X100, 150×4.6 mm, 5 µm) using an eluent containing 97.5% of aqueous 0.8 g/L (5.8 mM) p-hydroxybenzoic acid at pH 9.4 with 2.5% methanol, pumped at 1.5 mL/min at 30 °C. Background reduced to ~123 µS/cm by XAMS suppressor with ASUREX-A100 automatic regenerator. A Waters ACQUITY Arc system with modules QSM-R and FTN-R were used together with a Waters 432 conductivity detector. Injection of 70 µL of ground tablet powder (1 g) that had been diluted in mobile phase (50 mL), sonicated and filtered through 0.45 µm PES (solid line), or of a standard with 15 ppm sulfamate and 15 ppm sulfate in eluent (broken line, offset by 50 µS/cm).

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