The Role of Quality by Design (QbD) in the Development and Validation of Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) Methods

Quality by Design (QbD) is an organized, scientific approach to pharmaceutical development that focuses on embedding quality into products and processes from the very beginning. In the context of Reverse Phase High-Performance Liquid Chromatography (RP-HPLC), QbD provides a solid framework for developing and validating methods, ensuring their reliability, reproducibility, and consistency. This review examines the integration of QbD principles in the development and validation of RP-HPLC methods, highlighting key aspects such as the Analytical Target Profile (ATP), risk assessment, Design of Experiments (DoE), and control strategies. By applying these principles, both researchers and practitioners can better understand method variability, ensure regulatory compliance, and improve the robustness and efficiency of analytical methods.