Development of a green HPLC method for the analysis of artesunate and amodiaquine impurities using Quality by Design.

This study focuses on development of a green hplc method for the analysis of artesunate and amodiaquine impurities using quality by design.. The research employs high-performance liquid chromatography (HPLC) techniques to address analytical challenges in the environmental field. Greening analytical methods has become of great interest in the field of pharmaceutical analysis to protect both the operators' health and the environment. In this work, an innovative methodology combining Quality-by-Design (QbD) and Green Chemistry principles was followed to develop a single, green and robust RP-HPLC method for the quantitative... Research Background and Significance High-performance liquid chromatography (HPLC) remains a cornerstone analytical technique in pharmaceutical and environmental sciences for the separation, identification, and quantification of chemical compounds and impurities. The growing global emphasis on sustainable development and environmental protection has propelled the integration of green chemistry principles into analytical method development. This is particularly important when analyzing pharmaceuticals that may impact environmental matrices, such as artesunate and amodiaquine — two antimalarial agents widely used in public health. Impurities in these drugs can have environmental and safety implications, necessitating reliable, sensitive, and eco-friendly analytical methods. The study by Yabré et al. (2020) addresses this need by employing Quality by Design (QbD) principles to develop an innovative, green, and robust reversed-phase HPLC (RP-HPLC) method. This approach aligns with current trends aiming to reduce hazardous solvent use, minimize waste generation, and ensure method robustness and reproducibility, ultimately contributing to safer environmenta