Abstract

ASSESSMENT OF THE STABILITY OF GABAPENTIN UNDER DIFFERENT STRESS CONDITIONS

Abutalib Alamin Abdallah*, Dhia Eldin Abd Elmagied Elhag, Alnada Abdalla Mohamed Ibrahim, Mohamed Alamin Awad Alla, Mohammed Abdeen, Alaa E. Elawni

ABSTRACT

The aim of this study is to assess the stability of gabapentin under different stress conditions. This was achieved by using different physical and chemical tests i.e. acid/ base hydrolysis, oxidation (H2O2), direct sunlight, temperature, humidity and a combination of temperature and relative humidity. Gabapentin was found to be stable when subjected to acid hydrolysis (0.1 M HCl), dry temperature, temperature with relative humidity, sun light. The drug showed instability when subjected to acid hydrolysis (1M HCl) with and without heating, base hydrolysis (0.1 M NaOH) , 1 M NaOH, 1 M NaOH with temperature and when subjected to 1% hydrogen peroxide at ambient temperature and at 65ºC.

Keywords: Gabapentin, forced degradation, stressed conditions, stability, hydrolysis.