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在其酸水解产物存在的情况下,用分光光度法测定法匹拉韦。

Spectrophotometric determination of favipiravir in presence of its acid hydrolysis product.

作者信息

Sharaf Yasmine Ahmed, Abd El-Fattah Mai H, El-Sayed Heba M, Hegazy Maha A

机构信息

Department of Analytical Chemistry, Faculty of Pharmacy, Zagazig University, Zagazig, 44519, Egypt.

Pharmaceutical Analytical Chemistry Department, College of Pharmaceutical Sciences and Drug Manufacturing, Misr University for Science & Technology, Giza, 12566, Egypt.

出版信息

BMC Chem. 2023 Sep 30;17(1):129. doi: 10.1186/s13065-023-01046-6.

Abstract

Favipiravir (FAV) has been approved as an antiviral drug used in pandemic corona virus to treat covid-19. It has an amide moiety susceptible to hydrolysis and degradation in acid medium. Therefore, four simple, sensitive, and accurate stability indicating spectrophotometric methods have been developed for the determination of FAV in presence of its acid induced degradation product. The first method describes direct determination of FAV at 323 nm. Dual wavelength method was the second developed one for FAV quantitation by recording the absorbance difference at 322.7 and 270 nm. The third method involves using first derivative peak to peak amplitude at 338.0 and 308.0 nm, while difference spectrophotometry was the fourth suggested method, and it was based on recording the spectral changes at 361.3 nm as pH changes. The obtained calibration curves were linear over 4.0-22.0 µg/mL. Accuracy of the suggested procedures ranged from 99.11 to100.06, while precision results were from 0.80 to1.68. The developed methods were used to determine FAV in pure powdered form, laboratory-prepared mixtures with their degradation product, and pharmaceutical formulation without interference from its acidic degradation product.The greenness was assessed based on GAPI and ACREE metric and was found to be compatible and in reconciliation with green analytical chemistry concepts.

摘要

法匹拉韦(FAV)已被批准作为一种抗病毒药物,用于治疗新型冠状病毒肺炎(COVID-19)。它含有一个酰胺基团,在酸性介质中易水解和降解。因此,已开发出四种简单、灵敏且准确的稳定性指示分光光度法,用于在其酸诱导降解产物存在的情况下测定FAV。第一种方法描述了在323nm处直接测定FAV。双波长法是第二种开发的用于FAV定量的方法,通过记录在322.7和270nm处的吸光度差值来实现。第三种方法涉及使用在338.0和308.0nm处的一阶峰峰值幅度,而差示分光光度法是第四种建议的方法,它基于记录随着pH变化在361.3nm处的光谱变化。获得的校准曲线在4.0 - 22.0μg/mL范围内呈线性。所建议方法的准确度范围为99.11%至100.06%,精密度结果为0.80%至1.68%。所开发的方法用于测定纯粉末形式的FAV、与其降解产物的实验室制备混合物以及药物制剂中的FAV,不受其酸性降解产物的干扰。基于GAPI和ACREE指标评估了绿色度,发现其与绿色分析化学概念兼容且相符。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d1c1/10542695/983d759a16ea/13065_2023_1046_Fig1_HTML.jpg

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