Ahmed Amal B, Abdelrahman Maha M, Edrees Fadwa H
Pharmaceutical Chemistry Department, Faculty of Pharmacy, Nahda University (NUB), Sharq El-Nile, Beni-Suef, 62511, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Beni-Suef University, Alshaheed Shehata Ahmad Hegazy St, Beni-Suef, 62514, Egypt.
BMC Chem. 2025 Jan 9;19(1):11. doi: 10.1186/s13065-024-01364-3.
Coronavirus disease 2019 (COVID-19), an extremely contagious illness, has posed enormous challenges to healthcare systems around the world. Although the evidence on COVID-19 management is growing, antiviral medication is still the first line of treatment. Therefore, it is critical that effective, safe, and tolerable antivirals be available to treat early COVID-19 and stop its progression. Recently, favipiravir (FAV) has received FDA approval as safe and effective antiviral medication for COVID-19 management. Nitazoxanide (NTZ) also possesses antiviral and immunomodulating activities. Moreover, FAV and NTZ in combination are clinically used in COVID-19 treatment with reported safety, synergistic antiviral and immunomodulating effects. Despite the availability of various clinical studies on both FAV and NTZ, no existing analytical application for the simultaneous estimation of FAV and NTZ exists. As a result, the current work goal is to establish a green HPLC method for their analysis and implementation to human plasma. The developed method utilizes isocratic elution with 0.1% aqueous formic acid: ethanol (55:45, v/v) and dantrolene as internal standard. The bioanalytical validation parameters passed the FDA acceptance criteria. NEMI, eco scale, AGREE and ComplexGAPI approaches were used for qualitative and quantitative evaluation of the method's greenness.
2019冠状病毒病(COVID-19)是一种极具传染性的疾病,给全球医疗系统带来了巨大挑战。尽管关于COVID-19治疗的证据不断增加,但抗病毒药物仍然是一线治疗方法。因此,提供有效、安全且可耐受的抗病毒药物来治疗早期COVID-19并阻止其进展至关重要。最近,法匹拉韦(FAV)已获得美国食品药品监督管理局(FDA)批准,作为用于COVID-19治疗的安全有效的抗病毒药物。硝唑尼特(NTZ)也具有抗病毒和免疫调节活性。此外,FAV和NTZ联合用于COVID-19治疗,据报道具有安全性、协同抗病毒和免疫调节作用。尽管有关于FAV和NTZ的各种临床研究,但目前尚无同时测定FAV和NTZ的分析应用。因此,当前的工作目标是建立一种绿色高效液相色谱(HPLC)方法,用于它们的分析并应用于人体血浆。所开发的方法采用等度洗脱,流动相为0.1%甲酸水溶液:乙醇(55:45,v/v),并以丹曲林作为内标。生物分析验证参数通过了FDA的验收标准。使用NEMI、生态标尺、AGREE和ComplexGAPI方法对该方法的绿色度进行定性和定量评估。