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

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-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-