Pharmaceutical Analytical Chemistry Department, College of Pharmaceutical Sciences and Drug Manufacturing, Misr University for Science and Technology, 6th of October City, Giza, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr Al-Aini Street, Cairo, 11562, Egypt.
Sci Rep. 2024 Jul 16;14(1):16460. doi: 10.1038/s41598-024-66462-7.
A novel, highly sensitive and eco-friendly micellar-mediated spectrofluorimetric method was developed and validated for the determination of the novel antiparkinsonian drug safinamide mesylate in the presence of its related precursor impurity, 4-hydroxybenzaldehyde. The proposed approach relies on increasing the inherent fluorescence emission at 296 nm of safinamide, by forming hydrogen bonds between the mentioned drug and sodium dodecyl sulfate in the micellar system using 0.1 N HCl as a solvent, following excitation at 226 nm. A thorough investigation was conducted into the experimental factors affecting spectrofluorimetric behavior of the studied drug. A linearity plot of safinamide over the concentration range of 10.0-1000.0 ng/mL against the relative fluorescence intensities was established. The proposed method demonstrated excellent sensitivity down to the nano-gram level with detection and quantitation limits of 1.91 and 5.79 ng/mL, respectively. The studied drug was effectively determined in Parkimedine Tablets. Furthermore, the proposed method allows for ultrasensitive quantification of safinamide in spiked human plasma, with satisfactory percentage recovery (98.97-102.28%). Additionally, the greenness assessment using the advanced green certificate classification approach, the complementary green analytical procedure index (Complex-GAPI), and the analytical GREEness metric approach (AGREE), along with the practicality check using the Blue Applicability Grade Index in addition to the all-inclusive overall whiteness evaluation using the RGB-12 model were carried out. The outcomes demonstrated the effectiveness and whiteness of the proposed technique. Clearly, the suggested approach has the advantages of being simple, requiring no pretreatment steps, and relying solely on direct measuring procedures.
一种新颖、高灵敏度且环保的胶束介导荧光光谱法已被开发并验证,可用于在其相关前体杂质 4-羟基苯甲醛存在的情况下测定新型抗帕金森病药物甲磺酸沙芬酰胺。该方法依赖于在胶束体系中通过所述药物与十二烷基硫酸钠之间形成氢键,在 0.1N HCl 作为溶剂的情况下,在 226nm 激发下,增加甲磺酸沙芬酰胺的固有荧光发射,在 296nm 处。对影响研究药物荧光光谱行为的实验因素进行了深入研究。建立了甲磺酸沙芬酰胺在 10.0-1000.0ng/mL 浓度范围内与相对荧光强度的线性图。该方法表现出出色的灵敏度,检测限和定量限分别达到 1.91 和 5.79ng/mL。该方法可有效测定 Parkimedine 片剂中的甲磺酸沙芬酰胺。此外,该方法可用于在人血浆中进行超灵敏的甲磺酸沙芬酰胺定量,回收率满意(98.97-102.28%)。此外,使用先进的绿色证书分类方法、补充的绿色分析程序指数(Complex-GAPI)和分析绿色度度量方法(AGREE)进行绿色性评估,以及使用 Blue Applicability Grade Index 进行实用性检查,以及使用 RGB-12 模型进行全面的整体白色度评估,对该方法进行了评估。结果表明了该技术的有效性和白色度。显然,该方法具有简单、无需预处理步骤以及仅依赖直接测量程序的优点。