Abstract

ANALYTICAL QUALITY BY DESIGN (AQBD) APPROACH IN UV SPECTROSCOPIC METHOD DEVELOPMENT: CURRENT TRENDS AND APPLICATIONS

R. Revathi*, V. Ganesan, P. Muneeswaran, A. Mohammed Riyas, R. Paramaguru,
R. Nithinkumar

ABSTRACT

Analytical Quality by Design (AQbD) has become a structured,scientific and risk-based methodology of creating reliable androbust methodologies of analysis within the pharmaceuticalindustry. As opposed to traditional trial and error methods,AQbD combines preconceived goals, risk analysis tools andstatistical optimization methods to provide uniformity in theperformance of analytical processes throughout the methodlifecycle. The adoption of AQbD principles in the developmentof ultraviolet (UV) spectrophotometric methods has receivedconsiderable interest in recent years because of the simplicityof the technique, its affordability and common use in regularquality control. This review is a critical summary of recentdevelopments (2016-2025) in development and validation ofAQbD-driven UV spectroscopic methods. It pays attention tothe definition of the Analytical Target Profile (ATP), thecritical method variants (CMVs), the implementation of Designof Experiments (DoE) models like Central Composite Design(CCD) and factorial designs, and creation of method robustness and design space. New trendssuch as integration of green analytical chemistry and UV techniques that indicate stability are also introduced. The review shows that AQbD enhances reliability of the method used, flexibilities of regulations and lifecycle management, which makes the analysis in the pharmaceutical analysis stronger in terms of quality assurance of the analysis.

Keywords: AQbD approach, Design of Experiment, Input Variable, Risk Factors, Quality Product.