El-Kafrawy Dina Salah, Abo-Gharam Amira H
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Alexandria University, Elmessalah, Alexandria, 21521, Egypt.
BMC Chem. 2025 Mar 28;19(1):83. doi: 10.1186/s13065-025-01439-9.
The pursuit of sustainability in analytical chemistry is a multifaceted, challenging and complex endeavor. This requires continuous and competitive attempts to achieve the sustainable development goals at every step of the analytical methodology by adhering to the principles of green, blue and white analytical chemistry. This also involves assessment of the degree of sustainability using the latest evaluation metrics until finally reaching the design of a trichromatic procedure. The herein illustrated work represents a comparative study between two newly developed normal-phase and reverse-phase HPTLC methods for the simultaneous quantitative determination of Remdesivir (RMD), Favipiravir (FAV) and Molnupiravir (MOL). For normal-phase HPTLC method, the employed mobile phase consisted of ethyl acetate: ethanol: water (9.4:0.4:0.25, v/v), while, for reverse-phase HPTLC procedure, a greener mobile phase was employed consisting of ethanol: water (6:4, v/v). For both methods, detection wavelength of RMD and MOL was 244 nm while FAV was detected at 325 nm. Both methods were validated following the International Council for Harmonisation (ICH) guidelines with respect to linearity, range, accuracy, precision and robustness. The two established methods were proved to be linear over the range of 50-2000 ng/band for FAV and MOL and over the range of 30-800 ng/band for RMD. The excellent linearities were proved by the high values of correlation coefficients not less than 0.99988. The developed methods were successfully applied for the determination of the three drugs in their bulk form and in their pharmaceutical formulations. Furthermore, a thorough comparative and integrative trichromatic evaluation of sustainability of the designed methods was performed. The Analytical Eco-Scale, the novel Modified Green Analytical Procedure Index (MoGAPI) (2024) and the Analytical GREEnness (AGREE) metrics were applied for greenness assessment and the recent Blue Applicability Grade Index (BAGI) (2023) tool was employed for blueness evaluation. Finally, the RGB12 model was implemented for appraisal of whiteness of the developed methods.
在分析化学中追求可持续性是一项多方面、具有挑战性且复杂的工作。这需要通过坚持绿色、蓝色和白色分析化学的原则，在分析方法的每一步持续进行且具有竞争力地努力实现可持续发展目标。这还涉及使用最新的评估指标来评估可持续性程度，直至最终设计出三色程序。本文所示的工作是对两种新开发的正相和反相高效薄层色谱法进行的比较研究，用于同时定量测定瑞德西韦（RMD）、法匹拉韦（FAV）和莫努匹拉韦（MOL）。对于正相高效薄层色谱法，所采用的流动相由乙酸乙酯：乙醇：水（9.4:0.4:0.25，v/v）组成，而对于反相高效薄层色谱法，采用了更环保的流动相，由乙醇：水（6:4，v/v）组成。对于这两种方法，RMD和MOL的检测波长为244 nm，而FAV在325 nm处检测。两种方法均按照国际协调理事会（ICH）指南在线性、范围、准确度、精密度和稳健性方面进行了验证。所建立的两种方法在FAV和MOL的50 - 2000 ng/条带范围内以及RMD的30 - 800 ng/条带范围内被证明是线性的。相关系数的高值不低于0.99988证明了良好的线性。所开发的方法成功应用于三种药物原料药及其制剂的测定。此外，对所设计方法的可持续性进行了全面的比较和综合三色评估。应用分析生态尺度、新型改进绿色分析程序指数（MoGAPI）（2024）和分析绿色度（AGREE）指标进行绿色度评估，并采用最新的蓝色适用性等级指数（BAGI）（2023）工具进行蓝色度评估。最后，实施RGB12模型对所开发方法的白色度进行评估。
