Comprehensive Greenness, Blueness, and whiteness assessment of a sustainable RP-HPLC method for Atazanavir and Ritonavir with Forced degradation studies

This study presents the novel green analytical method for the simultaneous estimation of Atazanavir and Ritonavir in pharmaceutical dosage forms, employing ethanol as a sustainable solvent. Conventional Chromatographic methods frequently rely on acetonitrile/methanol, which poses environmental and health hazards. The developed RP-HPLC method optimizes the chromatographic conditions to align with the Green Analytical Chemistry principles. The method was validated per the ICH Q2 A&B guidelines, assessing ‘system suitability, linearity, accuracy, precision, robustness, and forced degradation studies. A comprehensive green metrics assessment using AGREE, GAPI, and COMPLEX GAPI confirmed the method’s environmental sustainability. The method demonstrated excellent linearity (r2 ≥ 0.999), high accuracy (99.86–100.16 % recovery), and precision (% RSD ≤ 2.0). Forced degradation showed acceptable levels of degradation for the drug product (5–20 %) according to the ICH Q1B guidelines. Compared to traditional methods using analytical indexes of AGREE, GAPI, COMPLEX GAPI, RAPI, BAGI, and RGB(White analytical chemistry), this approach significantly reduces solvent waste and enhances sustainability, making it ideal for routine pharmaceutical analysis.