Quality by Design (QbD) approach to develop HPLC method for eberconazole nitrate: Application oxidative and photolytic degradation kinetics

Abstract

Stability of eberconazole nitrate (EBZ) was investigated using a stability indicating HPLC method. Quality by Design (QbD) approach was used to facilitate method development. EBZ was exposed to different stress conditions, including hydrolytic (acid, base, neutral), oxidative, thermal and photolytic. Relevant degradation was found to take place in all the conditions. The degradation of EBZ followed (pseudo) first-order kinetics under experimental conditions. The kinetic parameters (rate constant, t1/2, and t90) of the degradation of EBZ were calculated.

Keywords

• Eberconazole nitrate
• QbD approach
• Stability indicating HPLC
• Degradation kinetics