School of Pharmaceutical Sciences, UNESP - Universidade Estadual Paulista, Araraquara, SP, Brazil.
School of Pharmaceutical Sciences, UNESP - Universidade Estadual Paulista, Araraquara, SP, Brazil.
Talanta. 2020 Mar 1;209:120532. doi: 10.1016/j.talanta.2019.120532. Epub 2019 Nov 2.
Besifloxacin is an important antimicrobial agent, belonging to the class of fluoroquinolones, used in the treatment of infectious conjunctivitis. Quality control of this active pharmaceutical ingredient is essential, since poor quality antimicrobials may contribute to the aggravation of the worrying picture of bacterial resistance. Thus, analytical methods need to be developed, validated and improved for that purpose. It is also important that these methods be environmentally friendly, as ensuring the quality of products without harming the environment meets the global needs. The aim of the study was the development and validation of a miniaturized turbidimetric microbiological method for the analysis of besifloxacin hydrochloride (BSF) in ophthalmic suspension. The analyzes were performed in 96-well microplates using Staphylococcus epidermidis ATCC 12228 as test microorganism and BHI broth. The method was validated according to ICH guidelines and showed to be linear (in a range of 0.5-8.0 μg mL), precise, accurate, robust and selective. Study of photo-degradation kinetics of BSF sample showed a zero order reaction. A comparative study with a previously validated HPLC method showed that the methods are interchangeable. This work shows the great potential of the proposed method of being introduced in routine analyzes of quality control of BSF in ophthalmic suspension as an option in line with the principles of Green Chemistry.
贝西沙星是一种重要的抗菌药物，属于氟喹诺酮类，用于治疗传染性结膜炎。该活性药物成分的质量控制至关重要，因为质量差的抗菌药物可能会加剧细菌耐药性令人担忧的局面。因此，需要开发、验证和改进分析方法。同样重要的是，这些方法要对环境友好，因为在不损害环境的情况下确保产品质量符合全球需求。本研究旨在开发和验证一种用于分析眼用混悬剂中盐酸贝西沙星（BSF）的小型比浊微生物学方法。分析在 96 孔微孔板中进行，使用表皮葡萄球菌 ATCC 12228 作为测试微生物和 BHI 肉汤。该方法按照 ICH 指南进行验证，结果表明该方法具有线性（在 0.5-8.0μg/mL 范围内）、精确、准确、稳健和选择性。BSF 样品光降解动力学研究表明该反应为零级反应。与之前验证的 HPLC 方法的比较研究表明，这两种方法是可互换的。这项工作表明，所提出的方法具有很大的潜力，可以作为符合绿色化学原则的选择，引入眼用混悬剂中 BSF 的常规质量控制分析中。
