ECO-ANALYTICAL STABILITY-INDICATING LC METHOD FOR EPLERENONE AND DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE: EVALUATION USING ECO ANALYTICAL SCALE, AGREE PREP, BAGI, AND COMPLEX GAPI

Abstract

The integration of green analytical chemistry (GAC) principles into method development is essential for aligning pharmaceutical analysis with sustainability goals. Within this outline, high-performance liquid chromatography (HPLC) remains a widely used technique, yet it’s based on organic solvents and energy-intensive processes highlights the need for greener method. In the present study, an HPLC method was developed, optimized, and validated for the simultaneous quantification of eplerenone and dapagliflozin propanediol monohydrate in bulk drug substances and laboratory-formulated tablets. Chromatographic separation was achieved on a Shimpack C18 column using a mobile phase consisting of phosphate buffer (pH 3.0, adjusted with 0.01% orthophosphoric acid), acetonitrile, and methanol in the ratio of 50:20:30 (v/v/v), with a flow rate of 1.0 mL/min. Detection was performed at 225 nm. The method demonstrated robust linearity (r > 0.99 for both analytes), with limits of detection and quantification of 2.95 and 8.96 μg/mL for eplerenone, and 1.99 and 6.03 μg/mL for dapagliflozin propanediol monohydrate, respectively. Validation parameters, including accuracy, precision, and robustness, met the acceptance criteria outlined in ICH Q2(R2). Specificity was confirmed by effective resolution of the drugs from its degradation products produced under stress conditions. The environmental performance of the method was systematically evaluated using Eco-Scale, AGREEprep, BAGI, and Complex GAPI tools, all of which indicated low ecological impact and minimal hazard potential. Collectively, these findings establish the method as not only analytically reliable and regulatory compliant but also environmentally responsible, thereby offering a sustainable approach for routine quality control in pharmaceutical laboratories.