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胶束强化荧光分光光度法测定福替尼原料药及人尿中福替尼的优化研究

Response surface methodology for optimization of micellar-enhanced spectrofluorimetric method for assay of foretinib in bulk powder and human urine.

机构信息

Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia; Department of Analytical Chemistry Faculty of Pharmacy, Cairo University, Kasr El-Aini St., Cairo 11562, Egypt.

Department of Pharmaceutical Chemistry, College of Pharmacy, King Saud University, Riyadh 11451, Saudi Arabia; Department of Chemistry, Faculty of Science and Technology, Al-Neelain University, Khartoum, Sudan.

出版信息

Spectrochim Acta A Mol Biomol Spectrosc. 2021 Aug 5;257:119811. doi: 10.1016/j.saa.2021.119811. Epub 2021 Apr 15.

DOI:10.1016/j.saa.2021.119811
PMID:33892248
Abstract

This work investigates a sensitive and precise enhanced spectrofluorimetric assay for assay of foretinib (FTB); a tyrosine kinase inhibitor drug used for treatment of breast cancer, in tablets and urine through response surface optimization by micelle mediated protocol. The basis of the described method is the enhancement of the fluorescence behavior of FTB in Cremophor RH 40 (Cr RH 40) micellar medium and measuring the fluorescence of FTB at 344 nm after excitation at 245 nm. Optimization was performed through evaluation of diluting solvent, types of organized media, buffer type and its relevant pH. Response surface methodology was applied to obtain the optimized values of variables that mostly affect interaction of Cr RH 40 with FTB using Box-Behnken design. ICH guidelines were adhered for the validation of merit figures. Acceptable linear relationship was obtained between relative fluorescence intensity (RFI) and FTB concentrations in the range of 50 - 1000 µg L, with correlation coefficient of 0.998. Accuracy was ≥ 99.82% and calculated limit of detection (LOD) was 10.60 µg L. Method applications included FTB assaying in pure bulk powder. Furthermore, applications on urine samples were performed with accuracy of 100.59 ± 3.40%. The method represents echo-friendly approach and effective alternating methodology to the relevant analytical ones for FTB assaying.

摘要

本工作研究了一种灵敏且精确的增强荧光分析测定法,用于测定福瑞替尼(FTB);一种用于治疗乳腺癌的酪氨酸激酶抑制剂药物,通过胶束介导的方案进行响应面优化来测定片剂和尿液中的福瑞替尼。所描述方法的基础是在吐温 RH 40(Cr RH 40)胶束介质中增强 FTB 的荧光行为,并在 245nm 激发后测量 FTB 的荧光在 344nm 处。通过评估稀释溶剂、组织介质类型、缓冲液类型及其相关 pH 值来进行优化。应用响应面法,使用 Box-Behnken 设计获得对最能影响 Cr RH 40 与 FTB 相互作用的变量的优化值。ICH 指南用于验证优点数据。在 50-1000μg/L 的范围内,相对荧光强度(RFI)与 FTB 浓度之间获得可接受的线性关系,相关系数为 0.998。准确度≥99.82%,计算出的检测限(LOD)为 10.60μg/L。该方法的应用包括对纯散装粉末中的 FTB 进行测定。此外,还对尿液样品进行了测定,准确度为 100.59±3.40%。该方法代表了对 FTB 测定的相关分析方法的友好型和有效替代方法。

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