Al-Farhan Badriah Saad, Saleh Safaa F, Ibrahim Angum M M, Alossaimi Manal A, Hassan Dalin A, Sallam Sahar, Naguib Ibrahim A, Obaydo Reem H, Hamad Ahmed Abdulhafez
Chemistry Department, Faculty of Science, King Khalid University, Abha 61421, Saudi Arabia.
Pharmaceutical Chemistry and Pharmacognosy Department, College of Pharmacy, Jazan University, Jazan 45142, Saudi Arabia; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Fayoum University, Fayoum 63514, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2025 Dec 15;343:126457. doi: 10.1016/j.saa.2025.126457. Epub 2025 May 28.
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.
本研究提出了一种创新的荧光光谱分析方法,用于对用于过敏治疗的第二代抗组胺药倍他司汀(BTT)进行环境友好且高灵敏度的定量分析。通过利用在温和酸性条件下BTT与赤藓红B(一种无毒的食品级染料)之间快速形成静电复合物,该方法实现了在556 nm处的荧光猝灭,从而能够精确检测BTT。关键创新点包括:首次使用赤藓红B作为BTT的荧光探针,为传统试剂提供了一种无毒且注重环保的替代方案;采用单步水基程序,消除了挥发性有机溶剂,符合绿色化学原则;具有出色的分析性能,在150 - 1600 ng/mL的线性范围内,检测限和定量限分别为39 ng/mL和118 ng/mL;使用绿色和白色分析化学框架进行全面的可持续性评估,获得了卓越的绿色度、高RGB快速白度和良好的蓝色度分数。该方法按照国际协调理事会(ICH)指南进行了全面验证,确保了稳健性、可重复性以及对纯BTT、药物制剂和各种样品基质的适用性,为药物分析提供了一种可持续、经济高效的解决方案。