A COMPREHENSIVE REVIEW ON ADVANCING PHARMACEUTICAL ANALYSIS THROUGH ANALYTICAL QUALITY BY DESIGN (AQBD)

Manish Kumar Barala*, Dr. Mukesh Bansal, Dr. Dilip Agrawal

Background: Pharmaceutical analytical methods are very important for ensuring drug quality. However traditional methods often rely on trial and error. This can lead to methods that're not very robust or flexible. Analytical Quality by Design (AQbD) is an approach. It uses science-based principles for analytical methods. Objective: This review looks at the basics, regulations, tools and uses of in reversed-phase high-performance liquid chromatography (RP-HPLC). RP-HPLC is widely used in analysis. Methods: We searched databases like PubMed and regulatory websites for information on AQbD, Quality by Design and RP-HPLC. We found publications from 2010 to 2025. Results: AQbD combines the Analytical Target Profile (ATP) risk assessment tools and Design of Experiments (DoE). This helps create a defined Method Operable Design Region (MODR).RP-HPLC methods created with AQbD are more robust. They are also more acceptable to regulators. These methods are used for: Assay of pharmaceutical ingredients (APIs), Impurity profiling, Dissolution testing, Stability-indicating methods, Bioanalytical quantification. AQbD is a big change in pharmaceutical analytical science. It follows ICH Q8–Q10 principles. With new technologies like artificial intelligence and automated platforms will become the standard for analytical method development. It helps create methods that're compliant, with regulations and aware of the whole lifecycle.