Graduate School of Pharmacy, Gujarat Technological University, Gandhinagar 382028, Gujarat, India.
Senores Pharmaceuticals Pvt. Ltd., Ahmedabad 380058, Gujarat, India.
Molecules. 2022 Aug 31;27(17):5606. doi: 10.3390/molecules27175606.
A novel stability-indicating, reversed-phase, high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination of favipiravir in an oral suspension. The effective separation of favipiravir and its degradation products was achieved on a Zorbax Eclipse Plus C18 column (5 μm particle size, 150 mm length × 4.6 mm diameter). The mobile phase was prepared by mixing 5 mM of phosphate buffer (pH 3.5) and methanol in a 75:25 ratio delivered at a 1.0 mL/min flow rate. The eluents were monitored using a photodiode array detector at a wavelength of 322 nm. The stability-indicating nature of this method was evaluated by performing force degradation studies under various stress conditions, such as acidic, alkali, oxidative, thermal, and photolytic degradation. Significant degradation was observed during the alkali stress degradation condition. The degradation products generated during various stress conditions were well separated from the favipiravir peak. In addition, the major degradation product formed under alkali stress conditions was identified using UPLC-ESI-TQ-MS/MS and NMR. Method validation was performed according to the ICH Q2 (R1) guideline requirements. The developed method is simple, accurate, robust, and reliable for routine quality control analysis of favipiravir oral suspensions.
开发并验证了一种用于测定口服混悬剂中珐匹拉韦的新型专属性、反相、高效液相色谱（RP-HPLC）法。珐匹拉韦与其降解产物在 Zorbax Eclipse Plus C18 柱（5μm 粒径，150mm 长度×4.6mm 直径）上实现了有效分离。流动相由 5mM 磷酸盐缓冲液（pH3.5）和甲醇以 75:25 的比例混合而成，流速为 1.0mL/min。洗脱液在 322nm 波长处使用光电二极管阵列检测器进行监测。通过在各种应力条件（如酸、碱、氧化、热和光降解）下进行强制降解研究，评估该方法的专属性。在碱应力降解条件下观察到明显的降解。在各种应力条件下产生的降解产物与珐匹拉韦峰很好地分离。此外，使用 UPLC-ESI-TQ-MS/MS 和 NMR 确定了在碱应力条件下形成的主要降解产物。该方法根据 ICH Q2（R1）指南要求进行了验证。所开发的方法简单、准确、稳健、可靠，可用于珐匹拉韦口服混悬剂的常规质量控制分析。
