Topiramate: A Review of Analytical Approaches for the Drug Substance, Its Impurities and Pharmaceutical Formulations.
An important step during the development of high-performance liquid chromatography (HPLC) methods for quantitative analysis of drugs is choosing the appropriate detector. High sensitivity, reproducibility, stability, wide linear range, compatibility with gradient elution, non-destructive detection of the analyte and response unaffected by changes in the temperature/flow are some of the ideal characteristics of a universal HPLC detector. Topiramate is an anticonvulsant drug mainly used for the treatment of different types of seizures and prophylactic treatment of migraine. Different analytical approaches to quantify topiramate by HPLC have been described because of the lack of chromophoric moieties on its structure, such as derivatization with fluorescent moieties and UV-absorbing moieties, conductivity detection, evaporative light scattering detection, refractive index detection, chemiluminescent nitrogen detection and MS detection. Some methods for the determination of topiramate by capillary electrophoresis and gas chromatography have also been published. This systematic review provides a description of the main analytical methods presented in the literature to analyze topiramate in the drug substance and in pharmaceutical formulations. Each of these methods is briefly discussed, especially considering the detector used with HPLC. In addition, this article presents a review of the data available regarding topiramate stability, degradation products and impurities.
Department of Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373, CCS, Bss, sala 15, Rio de Janeiro 21941-902, Brazil Department of Chemistry and Biochemistry, University of Texas at Arlington, Arlington, TX, USA edu.pharma.ufrj@gmail.com.
Eduardo Costa
EC
Pinto
Department of Chemistry and Biochemistry, University of Texas at Arlington, Arlington, TX, USA Department of Chemistry, Federal University of Santa Catarina, Florianopolis, Santa Catarina, Brazil.
Maressa Danielli
MD
Dolzan
Department of Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373, CCS, Bss, sala 15, Rio de Janeiro 21941-902, Brazil.
Lucio Mendes
LM
Cabral
Department of Chemistry and Biochemistry, University of Texas at Arlington, Arlington, TX, USA.
Daniel W
DW
Armstrong
Department of Pharmaceutics, Faculty of Pharmacy, Federal University of Rio de Janeiro, Av. Carlos Chagas Filho, 373, CCS, Bss, sala 15, Rio de Janeiro 21941-902, Brazil.
Valéria Pereira
VP
de Sousa
D000927:Anticonvulsants / Q000737:chemistry*; D002623:Chemistry Techniques, Analytical / Q000295:instrumentation / Q000379:methods*; D002626:Chemistry, Pharmaceutical; D005632:Fructose / Q000031:analogs & derivatives* / Q000737:chemistry; D000077236:Topiramate
D000927:Anticonvulsants; D000077236:Topiramate; D005632:Fructose