Mikhail Ibraam E, Elmansi Heba, Belal Fathalla, Ehab Ibrahim Adel
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Mansoura University, Mansoura 35516, Egypt.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Port-Said University, Egypt.
Microchem J. 2021 Jun;165:106189. doi: 10.1016/j.microc.2021.106189. Epub 2021 Mar 23.
Quality control (QC) of pharmaceutical products requires fast, sensitive as well as economic methodologies in order to provide high through output at low cost which are the main aspects considered by such economic facilities. Meanwhile, the ecological impacts must be considered by researchers to minimize the hazardous effects of research laboratories. Favipiravir (FAV) is an antiviral agent recently approved for treatment of COVID-19 infections during 2020 pandemic crisis, so the size of its production by international pharmaceutical corporations evolved dramatically within the past few months. Two novel simple, sensitive, and green methods were developed and validated for FAV determination based on solvent-free micellar LC and spectrofluorimetry techniques. To improve FAV native fluorescence, several factors were studied including solvent type, buffering, pH and added surfactants. The best sensitivity for FAV fluorescence was obtained in Britton-Robinson buffer (pH 4) at 436 nm after excitation at 323 nm within concentration range of 20-350 ng mL. Another HPLC method was validated using C18-RP (5 µm, 250 × 4.6 mm) stationary phase and solvent-free mobile phase consisting of (0.02 M Brij-35, 0.15 M SDS, and 0.02 M disodium hydrogen phosphate, pH 5.0) isocratically eluted at a flow rate of 1 mL min and detection wavelength of 323 nm. LC method was validated across concentration range of 10-100 µg mL and FAV eluted in 3.8 min. The methods were validated according to the FDA guidelines and were applied successfully for determination of FAV in its marketed tablet dosage forms and in spiked human plasma samples. The proposed methods are eco-friendly since they are typically based on biodegradable reagents in aqueous solvent-free phases, which was proven by their assessment on two recent greenness metrics (GAPI and AGREE) to prove their eco-friendly properties.
药品质量控制（QC）需要快速、灵敏且经济的方法，以便以低成本实现高产量，这是此类经济设施所考虑的主要方面。与此同时，研究人员必须考虑生态影响，以尽量减少研究实验室的有害影响。法匹拉韦（FAV）是一种抗病毒药物，最近在2020年大流行危机期间被批准用于治疗COVID-19感染，因此在过去几个月里，国际制药公司的法匹拉韦产量大幅增长。基于无溶剂胶束液相色谱和荧光光谱技术，开发并验证了两种新颖、简单、灵敏且绿色的法匹拉韦测定方法。为了提高法匹拉韦的天然荧光，研究了几个因素，包括溶剂类型、缓冲、pH值和添加的表面活性剂。在20 - 350 ng/mL浓度范围内，于323 nm激发后，在pH 4的Britton-Robinson缓冲液中，436 nm处获得了法匹拉韦荧光的最佳灵敏度。另一种高效液相色谱法使用C18-RP（5 µm，250×4.6 mm）固定相和由（0.02 M Brij-35、0.15 M SDS和0.02 M磷酸氢二钠，pH 5.0）组成的无溶剂流动相，以1 mL/min的流速等度洗脱，检测波长为323 nm。液相色谱法在10 - 100 µg/mL浓度范围内进行了验证，法匹拉韦在3.8分钟内洗脱。这些方法根据美国食品药品监督管理局（FDA）指南进行了验证，并成功应用于测定市售片剂剂型和加标人血浆样品中的法匹拉韦。所提出的方法是环保的，因为它们通常基于无溶剂水相中的可生物降解试剂，通过对最近的两个绿色指标（GAPI和AGREE）的评估证明了它们的环保特性。
