Stability Indicating Methods for Determination of Third Generation Antiepileptic Drugs and Their Related Substances

Abstract

The third generation of antiepileptic drugs that have been approved by international regulatory agencies between 2007 and 2018 include rufinamide, stiripentol, eslicarbazepine acetate, lacosamide, perampanel, brivaracetam and everolimus. As part of demonstrating their safety profile, stability indicating methods are developed to monitor these drugs and their impurities. In this context, this review describe some characteristics, impurities and the stability indicating methods used for the determination of these drugs and the presence of their related substances. Through a search in official compendia and scientific articles, fifty-six analytical methodologies were identified up to October 2020. The methodologies were developed using techniques of HPLC, UPLC, HPTLC, GC and UV/Vis spectrophotometry. A majority of the methods (∼70%) employed HPLC-UV. A number of these antiepileptic drugs were found to have had a small number of studies related to their stability and for the detection of impurities. The presentation of the current level of research on third generation antiepileptic drugs highlights the need for new stability and safety studies that are necessary to develop new pharmaceutical products containing these drugs.

Keywords:

• Antiepileptic drugs
• third generation
• stability indicating methods
• HPLC
• related substances

Acknowledgments

The authors acknowledge CAPES (Brasília, Brazil), CNPq (Brasília, Brazil) and FAPERJ (Rio de Janeiro, Brazil). We are grateful to William Provence Jr for English review.

Disclosure statement

The authors declare that there are no conflicts of interest.

Additional information

Funding

This article was funded by Conselho Nacional de Desenvolvimento Científico e Tecnológico;Coordenação de Aperfeiçoamento de Pessoal de Nível Superior;Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro.