A Green sustainable RP-HPLC method for simultaneous estimation of atazanavir and ritonavir: development, validation and environmental impact assessment

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 principles of Green Analytical Chemistry. The
method was validated per the ICH Q2 A& amp; 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 (r 2 ≥ 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 this approach significantly reduces solvent waste
and enhances sustainability making it ideal for routine pharmaceutical analysis.