Green chemistry integrated quality by design based RP-HPLC method for analysis of Itraconazole in pharmaceutical formulations

A robust and reliable reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the estimation of Itraconazole (ITZ) in pharmaceutical dosage forms. The method showed excellent linearity (R2 = 0.999) in the concentration range of 1–25µg/mL, high accuracy with recovery between 96.8 and 99.3%, and precision with %RSD less than 2.0%. The limits of detection (LOD) and quantification (LOQ) were 2.12µg/mL and 6.43µg/mL, respectively, confirming high sensitivity. Beyond conventional validation, the method was evaluated for sustainability using greenness and whiteness assessment tools (AGREE = 0.71, AGREEprep = 0.72, RAPI = 72.5, ComplexGAPI = 85, WAC = 72.5). The integrated evaluation confirmed that the analytical method is robust with moderate greenness, aligning with Green Analytical Chemistry (GAC) principles and partially contributing to the UN Sustainable Development Goals (SDGs).