Pharmaceutical Chemistry Department, College of Pharmacy, Prince Sattam Bin-Abdul Aziz University, PO Box 173, Al-Kharj 11942, Saudi Arabia; Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.
Spectrochim Acta A Mol Biomol Spectrosc. 2024 Sep 5;317:124371. doi: 10.1016/j.saa.2024.124371. Epub 2024 May 6.
A green, sensitive and rapid spectrofluorimetric method for quantitative assay of an anti-allergic medication composed of montelukast and fexofenadine mixture in raw materials and dosage form was developed. The method was based on measuring the synchronous fluorimetric peak without interference, pre-separation or pre-extraction procedures. Montelukast was analyzed at 360 nm while fexofenadine was measured at 263 nm using Δλ = 20 nm for both drugs using ethanol as diluting solvent and acetate buffer of pH 4. The assay was rectilinear over the concentration range of 1.0-10.0 μg/mL for fexofenadine and 0.1-0.6 μg/mL for montelukast. The method was full validated according to ICH guidelines. The applicability of the method enables the assay of both drugs in raw materials, synthetic mixture as well as combined tablets. Moreover, the greenness of the method was assessed using different methods including; analytical eco-scale, GAPI and AGREE. All of these methods confirm that the proposed method is an eco-friendly method.
建立了一种用于定量测定含有孟鲁司特和盐酸非索非那定混合物的抗变态反应药物的原料和剂型的绿色、灵敏、快速的荧光分光光度法。该方法基于测量无干扰、无需预分离或预提取的同步荧光峰。孟鲁司特在 360nm 处进行分析，而盐酸非索非那定在 263nm 处进行分析，两种药物均使用乙醇作为稀释溶剂，使用 pH 4 的醋酸缓冲液，Δλ=20nm。对于盐酸非索非那定，该测定在 1.0-10.0μg/mL 的浓度范围内呈线性关系，对于孟鲁司特，在 0.1-0.6μg/mL 的浓度范围内呈线性关系。该方法完全按照 ICH 指南进行了验证。该方法的适用性使得可以在原料、合成混合物以及组合片剂中同时测定两种药物。此外，还使用不同的方法（包括分析生态标度、GAPI 和 AGREE）评估了该方法的绿色性。所有这些方法都证实，所提出的方法是一种环保友好的方法。
