Simultaneous UV Spectroscopic estimation of Dapagliflozin, Sitagliptin, and Metformin in Tablets with Comprehensive Greenness Assessment Using Green Analytical Chemistry Metrics

Green analytical chemistry principles are essential in pharmaceutical method development to reduce environmental impact while maintaining analytical performance. To develop and validate a green, cost-effective UV spectrophotometric method for simultaneous estimation of Dapagliflozin (DAP), Sitagliptin (SIT), and Metformin (MET) in commercial tablet formulations. A simple UV spectrophotometric technique utilizing methanol as a common solvent was developed for quantification of DAP, SIT, and MET at their respective absorption maxima (223 nm, 267 nm, and 232 nm, respectively) using the simultaneous equation method. The method was validated according to ICH Q2(R1) guidelines for specificity, linearity, accuracy, precision, robustness, and sensitivity. Greenness assessment was performed using National Environmental Method Index (NEMI), Analytical Eco-Scale (AES), Green Analytical Procedure Index (GAPI), and AGREE metrics, with all parameters evaluated against the twelve principles of Green Analytical Chemistry (GAC). The developed method demonstrated excellent linearity (r² > 0.998) across concentration ranges of 0.1-0.5 µg/mL for DAP, 1-5 µg/mL for SIT, and 10-50 µg/mL for MET, with %RSD values < 2%, confirming good precision and accuracy. Recovery studies showed 98-102% recovery at all tested levels. Greenness assessment revealed NEMI pictograms with two green quadrants, Analytical Eco-Scale score of 82, GAPI evaluation with seven green and five yellow pentagrams, and AGREE score of 0.65, indicating excellent environmental performance. The developed UV spectrophotometric method is simple, cost-effective, and environmentally benign, providing an efficient analytical solution for routine quality control testing of triple antidiabetic fixed-dose combinations while adhering to modern green chemistry principles.