Experimental design in HPLC separation of pharmaceuticals

Design of Experiments (DoE) is an indispensable tool in contemporary drug analysis as it simultaneously balances a number chromatographic parameters to ensure optimal separation High Pressure Liquid Chromatography (HPLC). This manuscript briefly outlines the theoretical background DOE and provides step-by-step instruction for its implementation HPLC pharmaceutical practice. It particularly discusses classification various design types their possibilities rationalize different stages method development workflow, such selection most influential factors, factors optimization assessment robustness. Additionally, application DOE-based Analytical Quality by (AQbD) concept LC has been summarized. Recent achievements use stability-indicating hyphenated LC-MS methods have also reported. Performing Quantitative structure retention relationship (QSRR) study enhanced with data collection was recomended future perspective description system.