Review on analytical quality by design method of improved stability of drug

Abstract

The stability of pharmaceutical drugs is a critical factor affecting their efficacy, safety, and shelf-life. Traditional stability testing methods often lack efficiency and may not adequately predict real-world performance. Analytical Quality by Design (A QbD) has emerged as a systematic approach to ensure product quality by designing and controlling analytical procedures. This review explores the application of QbD methodologies in improving the stability of pharmaceutical drugs. The review begins with an overview of the principles of A QbD and its significance in pharmaceutical development. It then delves into the challenges associated with drug stability testing and the limitations of conventional approaches. Next, the application of A QbD principles in designing stability-indicating analytical methods is discussed, focusing on critical quality attributes (CQAs), risk assessment, and method development strategies. Finally, future directions and challenges in the application of A QbD for improving drug stability are discussed. Areas for further research and development, such as the integration of advanced analytical techniques and computational modelling, are identified to enhance the effectiveness of A QbD approaches in ensuring drug stability and quality.