Department of Pharmaceutical Chemistry, JSS College of Pharmacy, JSS Academy of Higher Education & Research, Mysuru 570015, India.
J Chromatogr Sci. 2023 Oct 3;61(8):750-757. doi: 10.1093/chromsci/bmac041.
The object of the analytical work is to develop an analytical multivariate optimization for the determination of Favipiravir (FAV), a SARS-CoV-2 molecule, by the reverse-phase liquid chromatographic method using the analytical quality by design approach. FAV is used as an antiviral drug. Box-Behnken design is utilized for the optimization of the experiment and to identify the critical method parameters like the volume of acetonitrile, temperature and flow rate. Further, these factors are used to design the suitable mathematical models and illustrate their effect on various responses. This newly developed method utilized C18 column (5μm, 100 × 4.6 mm) and a temperature of 40°C with a flow rate of 0.5 mL/min. The mobile phase is composed of acetonitrile and ammonium acetate buffer (pH 4), in the ratio of 20:80v/v and the wavelength of HPLC UV-Detector was fixed to 323nm. This method is validated according to International Council for Harmonization Q2 (R1) guidelines. The System suitability is performed and the retention time of Favipiravir is 3.4min. The linearity range is obtained at 0.062 - 4 μg/mL with a correlation coefficient (r2 = 0.9979). The recovery is found to be in the range of 98.84-100%. Thus, the intended method is found to be simple and robust.
分析工作的目的是开发一种分析多变量优化方法，用于通过反相液相色谱法使用分析质量设计方法来测定 SARS-CoV-2 分子法匹拉韦 (FAV)。FAV 用作抗病毒药物。Box-Behnken 设计用于优化实验并确定关键方法参数，如乙腈体积、温度和流速。此外，这些因素用于设计合适的数学模型，并说明它们对各种响应的影响。该新开发的方法利用 C18 柱（5μm，100×4.6mm）和 40°C 的温度，流速为 0.5mL/min。流动相由乙腈和乙酸铵缓冲液（pH4）组成，体积比为 20:80v/v，HPLC UV 检测器的波长固定在 323nm。该方法根据国际协调理事会 Q2（R1）指南进行验证。系统适用性进行，法匹拉韦的保留时间为 3.4min。线性范围在 0.062-4μg/mL 之间，相关系数（r2=0.9979）。回收率在 98.84-100%之间。因此，该方法被发现简单且稳健。
