Abstract

ANALYTICAL QUALITY BY DESIGN IN PHARMACEUTICAL ANALYTICAL ANALYSIS: A COMPREHENSIVE REVIEW OF PRINCIPLES, METHODOLOGIES, APPLICATIONS AND FUTURE PERSPECTIVES

Kalagoni Leela Bhavani, Rachakonda Sri Kavya, Peravali Anuhya, Darla Swarna Latha*

ABSTRACT

Analytical Quality by Design (AQbD) is a systematic and scientific strategy used to develop analytical methods with consistent and dependable performance. The approach begins by defining the intended analytical.[1] objectives and identifying the factors that can significantly influence method quality. Important analytical variables such as mobile-phase composition, pH, flow rate, column temperature, detection wavelength, and sample preparation can be systematically assessed during method development. Design of Experiments (DoE) is useful for evaluating the individual effects and interactions of these variables while reducing the number of experimental trials. Following optimization, the analytical procedure is assessed for important performance characteristics including accuracy, precision, specificity, robustness, and stability.[2] AQbD reduces dependence on conventional trial-and-error approaches and facilitates the development of reliable methods for assay determination, impurity profiling, dissolution testing, stability studies, and routine quality-control analysis. It also provides a structured framework for maintaining and improving analytical method performance throughout its lifecycle.

Keywords: Analytical Quality by Design (AQbD), pharmaceutical analysis, analytical method development, Analytical Target Profile (ATP), critical quality attributes, critical method parameters, risk assessment, design of experiments, method optimization, method vali