一种无溶剂高效液相色谱法，用于同时测定法维拉韦及其水解降解产物。
A solvent-free HPLC method for the simultaneous determination of Favipiravir and its hydrolytic degradation product.
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 and Technology, 6th of October City, Giza, 12566, Egypt.
出版信息
Sci Rep. 2023 Oct 28;13(1):18512. doi: 10.1038/s41598-023-45618-x.
During COVID-19 pandemic, Favipiravir (FPV) showed a great efficacy against COVID-19 virus, it produced noticeable improvements in recovery of the patients. The aim of this study was to develop a new, green and simple method for the simultaneous determination of FPV and its acid-induced degradation product (ADP) in its pure and pharmaceutical dosage forms. This method will be key for the inevitable development of FPV solution and inhaler formulations. A green micellar RP-HPLC method was developed using an RP-VDSPHERE PUR 100 column (5 µm, 250 × 4.6 mm) and an isocratic mixed micellar mobile phase composed of 0.02 M Brij-35, 0.1 M SDS and 0.01 M potassium dihydrogen orthophosphate anhydrous and adjusted to pH 3.0 with 1.0 mL min flow rate. The detection was performed at 280 nm with a run time of less than six min. Under the optimized chromatographic conditions, linear relationship has been established between peak area and concentration of FPV and its ADP in the range of 5-100 and 10-100 µg mL with elution time of 3.8 and 5.7 min, respectively. The developed method was validated according to the ICH guidelines and applied successfully for determination of FPV in its pharmaceutical dosage form.
在 COVID-19 大流行期间，法匹拉韦（FPV）对 COVID-19 病毒显示出了很好的疗效，它使患者的康复有了显著改善。本研究的目的是开发一种新的、绿色和简单的方法，用于同时测定 FPV 及其酸诱导的降解产物（ADP）在其纯品和药物制剂中的含量。这种方法将是 FPV 溶液和吸入剂制剂不可避免发展的关键。采用绿色胶束反相高效液相色谱法，使用 RP-VDSPHERE PUR 100 柱（5 µm，250×4.6 mm）和等度混合胶束流动相，由 0.02 M Brij-35、0.1 M SDS 和 0.01 M 磷酸二氢钾无水组成，并使用 1.0 mL/min 的流速调节 pH 值为 3.0。检测波长为 280 nm，运行时间不到 6 分钟。在优化的色谱条件下，FPV 及其 ADP 的峰面积与浓度在 5-100 和 10-100 µg/mL 范围内呈线性关系，洗脱时间分别为 3.8 和 5.7 min。该方法按照 ICH 指南进行了验证，并成功应用于药物制剂中 FPV 的测定。
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