Pharmaceutical Chemistry Department, College of Pharmacy, Al-Esraa University, Baghdad, 10045, Iraq.
Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al-Azhar University, Cairo, Egypt.
F1000Res. 2023 Aug 10;12:341. doi: 10.12688/f1000research.130861.1. eCollection 2023.
Tigecycline (TGC) is a recently developed antibiotic to battle resistant bacteria. The procedures outlined in the literature for analyzing TGC involve chemical solvents that could be hazardous. Therefore, this study aimed to create a sustainable and stable HPLC technique for quantifying Tigecycline in lyophilized powder. The powerful chemometric tool, experimental design (ED), will be applied to analyze the variables' interaction and impact on the selected analytical target profiles. Response surface methodology provides a tutorial on using the central composite design with three levels of variables and quadratic programming to optimize the design space of the developed method. The New HPLC method consisted of an aqueous buffer and ethanol as a green mobile phase run on a reversed-phase symmetry C18 column. A full resolution between the Tigecycline and its degradation product peaks was achieved in a short analytical runtime. Further, the specificity, accuracy, precision, robustness and stability indicating power of the proposed approach were verified through stress degrading testing. Finally, the analytical eco-scale and the green Analytical Procedure Index (GAPI) were utilized to determine how environmentally friendly the recommended method was compared to other published approaches.
替加环素（TGC）是一种新开发的抗生素，用于对抗耐药菌。文献中概述的分析 TGC 的程序涉及可能有害的化学溶剂。因此，本研究旨在开发一种可持续且稳定的 HPLC 技术，用于定量分析冻干粉末中的替加环素。强大的化学计量学工具，实验设计（ED），将用于分析变量之间的相互作用及其对所选分析目标谱的影响。响应面方法提供了一个关于使用三水平变量的中心复合设计和二次规划来优化开发方法设计空间的教程。新的 HPLC 方法由水缓冲液和乙醇作为绿色流动相在反相对称 C18 柱上运行。在短的分析运行时间内实现了替加环素与其降解产物峰之间的完全分离。此外，通过降解压力测试验证了所提出方法的专属性、准确性、精密度、稳健性和稳定性指示能力。最后，利用分析生态标度和绿色分析程序指数（GAPI）来确定与其他已发表方法相比，推荐方法的环保程度。
