Balancing Analytical Performance and Sustainability: AGSA and MA Tools-Assessed Fluorimetric Determination of Co-Administered Tadalafil and Omeprazole
Abstract
ABSTRACT A sensitive and environmentally sustainable spectrofluorimetric method was developed for the simultaneous determination of tadalafil (TAD) and omeprazole (OME) in pharmaceutical formulations and spiked human plasma. The method relies on the native fluorescence of TAD measured at λ_ex 280 nm and λ_em 330 nm, while OME was derivatized with 4‐chloro‐7‐nitrobenzo‐2‐oxa‐1,3‐diazole (NBD‐Cl) to form a highly fluorescent derivative measured at λ_ex 465 nm and λ_em 535 nm. Experimental variables affecting fluorescence intensity were systematically optimized. The method showed excellent linearity over the concentration ranges of 4–40 ng mL −1 for TAD and 30–2000 ng mL −1 for OME, with limits of detection of 1.15 and 8.94 ng mL −1 , respectively. The method was validated according to ICH guidelines and demonstrated satisfactory accuracy, precision, and selectivity. A successful application was achieved for the analysis of pharmaceutical dosage forms and spiked human plasma samples. The environmental sustainability of the method was evaluated using the Analytical Green Sustainability Assessment (AGSA) and the Multi‐color Assessment (MA) tool, confirming the excellent greenness and overall sustainability of the proposed analytical approach. The developed method provides a rapid, sensitive, and eco‐friendly alternative for routine quality control and bioanalytical applications.
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