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Article Abstract

This study presents an innovative spectrofluorimetric methodology for the environmentally friendly and highly sensitive quantification of Bepotastine (BTT), a second-generation antihistamine used in allergy treatment. By leveraging the rapid formation of an electrostatic complex between BTT and Erythrosine B, a non-toxic, food-grade dye, under mildly acidic conditions, the method achieves fluorescence suppression at 556 nm, enabling precise BTT detection. Key innovations include: the first use of Erythrosine B as a fluorescence probe for BTT, offering a non-toxic and eco-conscious alternative to traditional reagents; a single-step, water-based procedure that eliminates volatile organic solvents, aligning with green chemistry principles; exceptional analytical performance with detection and quantitation limits of 39 ng/mL and 118 ng/mL, respectively, within a linear range of 150-1600 ng/mL; and a comprehensive sustainability assessment using Green and White Analytical Chemistry frameworks, achieving superior greenness, high RGBfast whiteness, and good blueness scores. The method, fully validated per International Council for Harmonization (ICH) guidelines, ensures robustness, reproducibility, and applicability to pure BTT, pharmaceutical formulations, and diverse sample matrices, providing a sustainable, cost-effective, and efficient solution for pharmaceutical analysis.

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http://dx.doi.org/10.1016/j.saa.2025.126457DOI Listing

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Development of a sustainable fluorescence-based approach using erythrosine B dye for nanolevel quantification of bepotastine in eye drops and aqueous humor.

Spectrochim Acta A Mol Biomol Spectrosc

December 2025

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Al-Azhar University, Assiut Branch, Assiut 71524, Egypt. Electronic address:

This study presents an innovative spectrofluorimetric methodology for the environmentally friendly and highly sensitive quantification of Bepotastine (BTT), a second-generation antihistamine used in allergy treatment. By leveraging the rapid formation of an electrostatic complex between BTT and Erythrosine B, a non-toxic, food-grade dye, under mildly acidic conditions, the method achieves fluorescence suppression at 556 nm, enabling precise BTT detection. Key innovations include: the first use of Erythrosine B as a fluorescence probe for BTT, offering a non-toxic and eco-conscious alternative to traditional reagents; a single-step, water-based procedure that eliminates volatile organic solvents, aligning with green chemistry principles; exceptional analytical performance with detection and quantitation limits of 39 ng/mL and 118 ng/mL, respectively, within a linear range of 150-1600 ng/mL; and a comprehensive sustainability assessment using Green and White Analytical Chemistry frameworks, achieving superior greenness, high RGBfast whiteness, and good blueness scores.

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Bepotastine besilate (here after referred to as BTST), chemically known as ({d(S)4[4[(4chlorophenyl) (2pyridyl) methoxy] piperidino} butyric acid monobenzene sulphonate), is a second-generation antihistamine drug. To the best of our knowledge, no studies concerning the isolation or identification of process-related impurities have been reported so far. The current study reports the development and validation of a stability-indicating RP-HPLC method for the separation and identification of 5 potential impurities in bepotastine besilate.

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