General Courses Unit, Faculty of Sciences and Arts, King Khalid University, Dhahran Aljanoub, Saudi Arabia.
Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Al-Azhar University, Assiut Branch, Assiut 71524, Egypt.
Luminescence. 2021 May;36(3):651-657. doi: 10.1002/bio.3983. Epub 2020 Dec 2.
In this study, spectrofluorimetric and resonance Rayleigh scattering techniques were applied for the first time for determination of rupatadine through two validated methods. The proposed methods were based on a facile association complex formation between rupatadine and erythrosin B reagent in acidic medium. Spectrofluorimetric determination relied on the quenching effect of rupatadine on the fluorescence intensity of erythrosin B at 556 nm (excitation = 530 nm). Conversely, the resonance Rayleigh scattering (RRS) method relied on enhancement in the resonance Rayleigh scattering spectrum of erythrosin B at 344 nm after the addition of rupatadine. The developed methods produced linear results over ranges 0.15-2.0 μg/ml and 0.1-1.5 μg/ml, with detection limits of 0.030 μg/ml and 0.018 μg/ml for the spectrofluorimetric method and the RRS method, respectively. All reaction conditions for rupatadine-erythrosin B formation were optimized experimentally and both methods were validated according to International Council for Harmonisation guidelines. The developed methods were applied to estimate rupatadine content in its pharmaceutical tablet dosage form with acceptable recoveries. Furthermore, a content uniformity test for the commercial rupatadine tablets was successfully applied by the suggested spectroscopic methods according to United States Pharmacopeia guidelines.
在这项研究中,我们首次应用荧光光谱法和共振瑞利散射技术,通过两种经过验证的方法来测定鲁帕特丁。所提出的方法基于鲁帕特丁和酸性介质中赤藓红 B 试剂之间形成的简便缔合配合物。荧光光谱法测定基于鲁帕特丁对赤藓红 B 在 556nm 处(激发=530nm)荧光强度的猝灭效应。相反,共振瑞利散射(RRS)方法依赖于鲁帕特丁加入后赤藓红 B 在 344nm 处的共振瑞利散射光谱的增强。所开发的方法在 0.15-2.0μg/ml 和 0.1-1.5μg/ml 的范围内产生线性结果,荧光法和 RRS 法的检测限分别为 0.030μg/ml 和 0.018μg/ml。鲁帕特丁-赤藓红 B 形成的所有反应条件均通过实验优化,并且根据国际协调委员会的指导原则对两种方法进行了验证。所开发的方法用于估计其药物片剂制剂中鲁帕特丁的含量,回收率令人满意。此外,根据美国药典指南,建议的光谱方法成功地应用于商业鲁帕特丁片剂的含量均匀度测试。