The article reports on the development of an efficient, robust and sensitive HPLC-DAD method for the simultaneous determination of five fluoroquinolone-based antimicrobial drugs, namely ciprofloxacin, moxifloxacin, norfloxacin, ofloxacin and pefloxacin in both aquatic and tablet formulations. The robustness of the high-performance liquid chromatography with diode-array detection (HPLC-DAD) method has been evaluated through the concepts of quality-by-design (QbD) and full factorial design of experiments (DoEs), using a Minitab 17 statistical tool. The proposed method offers sequential separation with well-defined peak shape and resolution, and has also been evaluated by following international council for harmonization (ICH) pharmaceutical guidelines. A linear signal response has been achieved for the target fluoroquinolones (FQ) drugs in the concentration range of 45–20,000 ng/mL, with an average correlation coefficient (r²) value of 0.9997, and a data precision and accuracy range of 99.3–100.9%, with an RSD value of ≤0.95%, for hexaplicate measurements. The methodology offers superior sensitivity for the target FQ drugs, with the limit of detection (L_D) range of 10–25 ng/mL, and the limit of quantification (L_Q) range of 51–86 ng/mL, respectively. Using the proposed method, the article carries the first of its kind report in studying the degradation profile monitoring and drug assay determination in tablet formulations and under various physiological buffer stress conditions, for pharmaceutical validation.

中文翻译：

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通过按质量设计概念对氟喹诺酮类药物进行色谱分离和药物降解曲线监测

该文章报道了一种高效，稳健且灵敏的HPLC-DAD方法的开发，该方法可同时测定水和片剂中五种基于氟喹诺酮的抗菌药物，即环丙沙星，莫西沙星，诺氟沙星，氧氟沙星和培氟沙星。通过使用Minitab 17统计量的按设计质量（QbD）和实验全设计（DoE）的概念，评估了带二极管阵列检测（HPLC-DAD）方法的高效液相色谱法的耐用性。工具。所提出的方法提供了具有明确定义的峰形和分离度的顺序分离方法，并且还已经按照国际协调委员会（ICH）药物指南进行了评估。r ²）值为0.9997，六次测量的数据精度和准确度范围为99.3-100.9％，RSD值≤0.95％。该方法为目标FQ药物提供了更高的灵敏度，检测限（L _D）范围为10–25 ng / mL，定量限（L _Q）范围为51–86 ng / mL。使用所提出的方法，本文首次报道了片剂制剂中降解曲线监测和药物测定的研究，并在各种生理缓冲液应激条件下进行了药物验证。