Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.
Luminescence. 2022 Oct;37(10):1785-1792. doi: 10.1002/bio.4358. Epub 2022 Aug 16.
Two facile spectroscopic methodologies were designed for estimating trospium chloride (TPM) in raw material and tablets with high operational reliability and selectivity. The methods were based on using erythrosine B (EB) as a spectroscopic tool for ion-pair complex formation with the drug. In a mild acidic medium of Britton Robinson buffer (pH 4.0), the ionized hydroxyl group in the reagent interacted with the ionized amine in the studied drug. Method I was based on the spectrophotometric measuring of the absorbance of the reaction product at 557 nm. Method II was based on spectrofluorimetric measurement of the quenching effect of TPM on the inherent fluorescence of EB at 550 nm (λ = 528 nm). The two methods showed linearity through ranges 1.0-10.0 and 0.5-10.0 μg/ml for Methods I and II, respectively. The suggested methods were exploited for analyzing TPM in Trospamexin® tablets and showed good applicability. The designed systems were validated as per International Conference on Harmonization guidelines. Experimental conditions were modulated to obtain the best sensitivities. The quenching mechanism was investigated and the quenching constant was computed relying on the Stern-Volmer equation. Environmental impact was appraised using novel metric green tools, GABI, and AGREE. The suggested systems excelled over other reported methods in terms of greenness, sensitivity, and cost-effectiveness.
两种简便的光谱方法被设计用于在原材料和片剂中以高操作可靠性和选择性估计托品氯铵(TPM)。这些方法基于使用赤藓红 B(EB)作为与药物形成离子对配合物的光谱工具。在 Britten-Robinson 缓冲液(pH 4.0)的温和酸性介质中,试剂中的离子化羟基与研究药物中的离子化胺相互作用。方法 I 基于测量反应产物在 557nm 处的吸光度。方法 II 基于 TPM 对 EB 固有荧光的猝灭效应在 550nm(λ = 528nm)处的分光光度法测量。两种方法的线性范围分别为 1.0-10.0 和 0.5-10.0μg/ml。所提出的方法用于分析 Trospamexin®片剂中的 TPM,表现出良好的适用性。所设计的系统根据国际协调会议指南进行了验证。调节实验条件以获得最佳灵敏度。研究了猝灭机制,并根据 Stern-Volmer 方程计算了猝灭常数。使用新的绿色工具 GABI 和 AGREE 评估了环境影响。所提出的系统在绿色性、灵敏度和成本效益方面优于其他报道的方法。