Aboras Sara I, Megahed Ahmed A, El-Yazbi Fawzy, Maher Hadir M
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, University of Alexandria, Al-mesallah, Alexandria, 21521, Egypt.
Al-Basra Health Unit, Alamriya Medical Area, Ministry of Health, Alexandria, Egypt.
BMC Chem. 2024 Mar 7;18(1):50. doi: 10.1186/s13065-024-01147-w.
The cutting-edge combination of fluvoxamine (FVM) and ivermectin (IVM) has been presented as a proposed dosage form for the treatment of COVID-19 infections in early diagnosed patients. The main objective of this work is to develop simple, sensitive, and efficient methods for the synchronous quantification of FVM and IVM without any prior separation. Four green UV-methods were employed for the synchronous quantification, namely: Fourier functions convolution of absorption spectra, FFAS, Fourier functions convolution of derivative spectra of absorption curves, FFDS, Fourier function convolution of ratio spectra of absorption curves, FFRS and the dual-wavelength method, DWM. FFRS and DWM approaches can be able to reconcile the two components' significantly interfering spectrum presented in this commixture. Good linearity was checked in the range of 5-40, and 2.5-25 μg/mL for the FVM, and IVM, respectively. All approaches developed have been recommended in compliance with ICH principles. Furthermore, the approaches' greenness was predestined by "National Environmental Method Index" (NEMI), "Analytical GREEnness metric (AGREE)", the "Analytical Eco-Scale", and the "Green Analytical Procedure Index" (GAPI). In addition, spider diagram was utilized for the assessment of the greenness index of the solvent used. Beside greenness, the sustainability of our methods was investigated using the HEXAGON tool. Continuing the constant pursuit of greenness, drug-drug interactions (DDIs) between FVM & IVM were predicted by insilico tools to ensure the safety of the suggested mixture as a preliminary step before invitro and in vivo studies. Because they were deemed sustainable, affordable, and successful, the suggested UV-methods may be used for routine quality control investigations of the indicated formulations FVM & IVM.
氟伏沙明(FVM)和伊维菌素(IVM)的前沿组合已被提出作为一种用于治疗早期确诊COVID-19感染患者的剂型。这项工作的主要目的是开发简单、灵敏且高效的方法,用于在无需任何预先分离的情况下同步定量FVM和IVM。采用了四种绿色紫外方法进行同步定量,即:吸收光谱的傅里叶函数卷积(FFAS)、吸收曲线导数光谱的傅里叶函数卷积(FFDS)、吸收曲线比率光谱的傅里叶函数卷积(FFRS)以及双波长法(DWM)。FFRS和DWM方法能够协调该混合物中两种成分呈现出的显著干扰光谱。分别在5 - 40 μg/mL和2.5 - 25 μg/mL范围内对FVM和IVM进行了良好线性检查。所开发的所有方法均按照国际人用药品注册技术协调会(ICH)原则进行了推荐。此外,通过“国家环境方法指数”(NEMI)、“分析绿色度指标”(AGREE)、“分析生态量表”以及“绿色分析程序指数”(GAPI)预先确定了这些方法的绿色度。此外,利用蜘蛛图评估了所用溶剂的绿色度指数。除了绿色度之外,还使用HEXAGON工具研究了我们方法的可持续性。持续不断地追求绿色度,通过计算机模拟工具预测了FVM与IVM之间的药物相互作用(DDIs),以确保所建议混合物在体外和体内研究之前作为初步步骤的安全性。由于所建议的紫外方法被认为是可持续、经济实惠且成功的,因此可用于对指定制剂FVM和IVM进行常规质量控制研究。