eco-friendly rp-uplc method for simultaneous estimation of metformin and remogliflozin using aqbd principles

A robust and environmentally sustainable rp-uplc method was successfully developed and validated for the simultaneous estimation of remogliflozin and metformin in remo-m 500 tablets, following the analytical quality by design (aqbd) principles. a rotatable central composite design (ccd) was utilized to optimize the chromatographic conditions, focusing on the ethanol ratio and flow rate as critical variables. the optimized method employed a mobile phase with ethanol: triethylamine of ph-2.5/0.1% formic acid (43:57) at a flow rate of 0.5 ml/min and uv detection at 236 nm. metformin and remogliflozin showed retention times of 0.708 min and 1.624 min, respectively. excellent linearity was observed over the concentration ranges 125–750 µg/ml for metformin and 25-150 µg/ml for remogliflozin. the regression coefficients (r²) were 0.99947 for metformin and 0.99963 for remogliflozin, indicating a strong correlation between the concentration and peak area. sensitivity studies revealed lod and loq values of 0.6 µg/ml and 2 µg/ml for both drugs. precision and accuracy were confirmed with intraday and inter-day %rsd values below 2% and mean recoveries of 99.8%. the forced degradation study demonstrated that both metformin and remogliflozin were most susceptible to oxidative (peroxide) conditions, with up to 14.5% degradation, whereas minimal degradation was observed under thermal, reduction, and hydrolysis conditions, confirming the stability of the method. environmental assessments using gapi, amgs, and agree metrics demonstrated high sustainability, with an analytical eco-score (aes) of 97 and an agree score of 0.92. thus, the developed method provides a rapid, accurate, and eco-friendly approach for routine quality control of remogliflozin and metformin, supporting green analytical practices and minimizing environmental impact.