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食用色素诱惑红 B 作为一种有效的绿色探针定量测定抗癌药物舒尼替尼的应用。应用于药物制剂和人血浆。

Utility of the food colorant erythrosine B as an effective green probe for quantitation of the anticancer sunitinib. Application to pharmaceutical formulations and human plasma.

机构信息

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.

出版信息

Luminescence. 2023 Dec;38(12):2073-2085. doi: 10.1002/bio.4598. Epub 2023 Oct 10.

Abstract

Sunitinib is a tyrosine kinase inhibitor used for the treatment of renal cell carcinoma and gastrointestinal stromal tumors. In this study, two spectroscopic methods, spectrofluorometric and spectrophotometric, were utilized to quantify sunitinib in different matrices. In method I, the native fluorescence of erythrosine B was quenched by forming ion-pair complex with increasing quantities of sunitinib. This approach was utilized for measuring sunitinib in its dosage forms and spiked plasma. After excitation at 528 nm, the quenching of fluorescence is linearly related to the concentration across the range of 0.05-0.5 μg mL at 550 nm in Britton-Robinson buffer (pH 4.0), with a correlation value of 0.9999 and a high level of sensitivity with detection limit down to 10 ng mL . Method II relies on spectrophotometric measurements of the produced complex at 550 nm across a range of 0.5-10.0 μg mL , with good correlation value of 0.9999. This method has a detection limit down to 0.16 μg mL . The proposed methodologies were validated according to International Conference on Harmonization (ICH) guidelines with satisfactory results. The stoichiometry of the reaction was determined through the application of Job's method, while the mechanism of quenching was investigated by employing the Stern-Volmer plot. The designated methods were used to estimate sunitinib in its capsules and in spiked human plasma. Additionally, the statistical analysis of the data revealed no substantial differences when compared to previous reported spectroscopic method. Green assessment tools provide further details about the eco-friendly nature of the methods.

摘要

舒尼替尼是一种酪氨酸激酶抑制剂,用于治疗肾细胞癌和胃肠道间质瘤。在这项研究中,使用了两种光谱方法,荧光光谱法和分光光度法,来定量不同基质中的舒尼替尼。在方法 I 中,曙红 B 的本征荧光通过与舒尼替尼形成离子对复合物而被猝灭。该方法用于测量其制剂和加标血浆中的舒尼替尼。在 528nm 处激发后,在 Britton-Robinson 缓冲液(pH 4.0)中,在 550nm 处,荧光猝灭与浓度呈线性关系,在 0.05-0.5μgmL 范围内,相关值为 0.9999,具有较高的灵敏度,检测限低至 10ngmL 。方法 II 依赖于在 550nm 处产生的复合物的分光光度测量,范围为 0.5-10.0μgmL ,具有良好的相关值 0.9999。该方法的检测限低至 0.16μgmL 。所提出的方法根据国际协调会议(ICH)指南进行了验证,结果令人满意。通过应用 Job 法确定了反应的化学计量比,通过 Stern-Volmer 图研究了猝灭机制。指定的方法用于估计胶囊中的舒尼替尼和加标人血浆中的舒尼替尼。此外,数据的统计分析表明,与以前报道的光谱方法相比,没有显著差异。绿色评估工具提供了有关方法环保性质的更多详细信息。

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