A fluorescence-off based approach for sensitive determination of bepotastine in pharmaceutical and biological matrices considering human safety aspects: sustainability assessment

A pioneering spectrofluorimetric approach was established to facilitate the precise and environmentally considerate measurement of Bepotastine (BPST), a pharmaceutical compound utilized as a novel anti-allergy treatment. The study presents a highly dependable, sensitive, and green analytical procedure for the investigation and validation of this drug. The described methodology capitalizes on the rapid electrostatic interaction that occurs between Eosin Y and Bepotastine, a non-hazardous dye approved for biological staining use, under somewhat acidic pH settings. This interaction leads to fluorescence quenching of the bio-dye, predominantly at an emission wavelength of 556 nm. Outstanding analytical considerations were achieved, including detecting and measuring thresholds of 30.8 ng/mL and 93.5 ng/mL, respectively, across the linear working range of 100-1900 ng/mL. Extensive optimization studies were conducted to refine the conditions impacting the complexation mechanism between molecules of both the drug and the bio-dye. Rigorous validation demonstrated full compliance with ICH standards, confirming the method's accuracy and precision. The developed method demonstrated high analytical accuracy, with recovery values ranging from 98.63% to 100.15% (relative error: -0.15-1.37%), and excellent precision, reflected by SD and RSD values < 2.0%. The method also exhibited remarkable ruggedness and robustness (RSD ≤ 1.64%), confirming its reliability and suitability for advanced analytical applications. This novel procedure was effectively employed for the evaluation of BPST in its raw state, pharmaceutical formulations, and various matrices. From an ecological viewpoint, the procedure was thoroughly assessed for sustainability using advanced green chemistry tools. Comprehensive evaluation using eight internationally recognized green assessment tools (Analytical Eco-Scale, AGREE, MoGAPI, ComplexMoGAPI, CaFRI, CACI, BAGI, and AGSA) confirmed the superior greenness and analytical reliability of the proposed method, establishing it as a sustainable and efficient choice for routine determination of bepotastine in pharmaceutical and biological samples.