Analytical Quality by Design (QbD) Approach for Development and Validation of HPLC Method for Acyclovir: Application Degradation Kinetics

Abstract

Investigations on chemical behaviour of Acyclovir (ACY) are essential for determining stability properties during processing and storage conditions. The present work describes the stability and decomposition kinetics of ACY by using a stability indicating HPLC method. The experiments were designed with quality by design (QbD) approach to facilitate method development and optimization. Different stress conditions including hydrolytic (acid, base, neutral), oxidative, thermal and photolytic degradation were applied. Stability analysis reveals that relevant degradation occurs in all applied conditions. The proposed method was linear with precision and robustness values within acceptable limits.Under employed experimental conditions, the degradation of ACY followed (pseudo) first-order kinetics. The kinetic parameters (rate constant, t1/2, and t90) of the degradation of ACY were calculated.