High-performance liquid chromatographic study of topiramate and its impurities

A. Biró, É Pergel, G. Árvai, I. Ilisz, G. Szepesi, A. Péter, F. Lukács

Research output: Contribution to journalArticle

12 Citations (Scopus)

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.

Original languageEnglish
JournalChromatographia
Volume63
Issue numberSUPPL. 13
DOIs
Publication statusPublished - Jun 2006

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Impurities
Gradient methods
Liquids
Pharmaceutical Preparations
Diodes
Ions
Testing
High Pressure Liquid Chromatography
Guidelines
topiramate

Keywords

  • Column liquid chromatography
  • Inverse RI and UV
  • Method validation
  • Topiramate

ASJC Scopus subject areas

  • Analytical Chemistry
  • Clinical Biochemistry

Cite this

High-performance liquid chromatographic study of topiramate and its impurities. / Biró, A.; Pergel, É; Árvai, G.; Ilisz, I.; Szepesi, G.; Péter, A.; Lukács, F.

In: Chromatographia, Vol. 63, No. SUPPL. 13, 06.2006.

Research output: Contribution to journalArticle

Biró, A. ; Pergel, É ; Árvai, G. ; Ilisz, I. ; Szepesi, G. ; Péter, A. ; Lukács, F. / High-performance liquid chromatographic study of topiramate and its impurities. In: Chromatographia. 2006 ; Vol. 63, No. SUPPL. 13.
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