Aboras Sara I, Maher Hadir M, Alzoman Nourah Z, Elbordiny Haydi S
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Al-Mesallah, Alexandria University, Alexandria, 21521, Egypt.
College of Pharmacy, Department of Pharmaceutical Chemistry, King Saud University, P.O. Box 22452, 11495, Riyadh, Saudi Arabia.
BMC Chem. 2024 Sep 20;18(1):184. doi: 10.1186/s13065-024-01275-3.
The Food and Drug Administration (FDA) authorized the administration of ritonavir (RIT)-boosted nirmatrelvir (NMV) on May 25, 2023, for the treatment of mild to moderate COVID-19 in patients who are at high risk of developing severe COVID-19. In accordance with sustainability and environmental friendliness, simple, eco-friendly, and sustainable spectrophotometric methods were established for concurrently estimating RIT and NMV in newly launched copackaged pills. The suggested solutions for resolving the spectral overlap between RIT and NMV involve the following mathematical methods: the first derivative method (D), second derivative method (D), and dual-wavelength zero-order method (DWZ). When ethanol was used as a green dilution solvent, the linearity range was adjusted (10-250 µg/mL) for both drugs. The procedures resulted in a high correlation coefficient (not less than 0.9996) and satisfactory levels of detection and quantification. Additionally, method validation was performed in accordance with International Council for Harmonization norms. Moreover, a detailed ecological and sustainability evaluation protocol was established to confirm the greenness and whiteness of the methods. Finally, the proposed method, along with previously reported methods for analysing NMV and RIT, were reviewed analytically and ecologically.
2023年5月25日，美国食品药品监督管理局（FDA）批准使用利托那韦（RIT）增强型奈玛特韦（NMV），用于治疗有发展为重症COVID-19高风险的轻至中度COVID-19患者。本着可持续性和环境友好性原则，建立了简单、环保且可持续的分光光度法，用于同时测定新推出的复方包装药丸中的RIT和NMV。解决RIT和NMV光谱重叠问题的建议方法涉及以下数学方法：一阶导数法（D）、二阶导数法（D）和双波长零阶法（DWZ）。当使用乙醇作为绿色稀释溶剂时，两种药物的线性范围均调整为（10 - 250 µg/mL）。该方法具有高相关系数（不低于0.9996）以及令人满意的检测和定量水平。此外，按照国际协调理事会规范进行了方法验证。此外，还制定了详细的生态与可持续性评估方案，以确认这些方法的绿色度和白度。最后，对所提出的方法以及先前报道的分析NMV和RIT的方法进行了分析和生态方面的综述。
