Faculty of Pharmacy, Pharmaceutical Chemistry Department, Egyptian Russian University, Badr City, Cairo, Egypt.
Faculty of Pharmacy, Analytical Chemistry Department, Cairo University, Kasr El-Aini Street, Cairo, 11562, Egypt.
Sci Rep. 2024 May 27;14(1):12088. doi: 10.1038/s41598-024-61712-0.
Nowadays, scientists are currently attempting to lessen the harmful effects of chemicals on the environment. Stability testing identifies how a drug's quality changes over time. The current work suggests a first and sustainable differential pulse voltammetry technique for quantifying difluprednate (DIF) as an anti-inflammatory agent in the presence of its alkaline degradation product (DEG). The optimum conditions for the developed method were investigated with a glassy carbon electrode and a scan rate of 100 mV s. The linearity range was 2.0 × 10-1.0 × 10 M for DIF. DIF was found to undergo alkaline degradation, when refluxed for 8 h using 2.0 M NaOH, and DEG was successfully characterized utilizing IR and MS/MS. The intended approach demonstrated the selectivity for DIF identification in pure, pharmaceutical, and degradation forms. The student's t-test and F value were used to compare the suggested and reported approaches statistically. The results were validated according to ICH requirements. The greenness of the studied approach was evaluated using the Green Analytical Procedure Index and the Analytical Greenness metric. Additionally, the whiteness features of the proposed approach were examined with the recently released red, green, and blue 12 model, and the recommended strategy performed better than the reported approaches in greenness and whiteness.
如今，科学家们正试图减轻化学物质对环境的有害影响。稳定性测试确定了药物质量随时间的变化。目前的工作提出了一种差分脉冲伏安法，用于在碱性降解产物 (DEG) 存在下定量双氯芬酸 (DIF)，这是一种抗炎药物。在玻碳电极和扫描速率为 100 mV s 的条件下，对开发的方法的最佳条件进行了研究。DIF 的线性范围为 2.0×10-1.0×10 M。发现 DIF 在回流 8 小时后，用 2.0 M NaOH 会发生碱性降解，成功地利用 IR 和 MS/MS 对 DEG 进行了表征。所提出的方法表现出对纯药物、药物和降解形式的 DIF 识别的选择性。学生 t 检验和 F 值用于对所提出的方法和报道的方法进行统计学比较。结果根据 ICH 要求进行了验证。使用绿色分析程序指数和分析绿色度指标评估了所研究方法的绿色性。此外，还使用最近发布的红色、绿色和蓝色 12 模型对所提出方法的白色特征进行了检查，建议的策略在绿色性和白色性方面比报道的方法表现更好。
