Stability Studies and Shelf-Life Determination of Pharmaceutical Formulations

Abstract

Stability testing is a critical element in pharmaceutical development, ensuring the safety, efficacy, and quality of formulations throughout their shelf life. This paper focuses on the methodologies for conducting stability studies under International Council for Harmonisation (ICH) guidelines. Both accelerated and long-term studies were carried out for tablet formulations containing moisture-sensitive drugs. The formulations were stored under controlled conditions of temperature and humidity. Analytical techniques including UV spectrophotometry, HPLC, and differential scanning calorimetry were used to monitor degradation products and physical changes. Results revealed that the choice of excipients and packaging materials significantly influenced stability outcomes. Kinetic analysis of degradation data helped predict shelf life using the Arrhenius equation, enabling better formulation design and storage recommendations.

KEYWORDS: Stability studies, ICH guidelines, Degradation kinetics, Shelf-life prediction, Pharmaceutical quality