Background Modafinil (MDF) is one of the drugs used for the treatment of narcolepsy. Objective This manuscript describes the development and validation of two chromatographic stability-indicating methods for MDF in the presence of its acid-induced degradation product. Methods MDF was degraded under different stress conditions and identification of the degradation product was performed using IR and mass spectroscopy. The first method involved TLC, in which plates precoated with silica gel G60 F254 were used and the developing system was dichloromethane– methanol (9:1, v/v). The second method was an eco-friendly (HPLC) method that utilized a C-18 column and ethanol–H2O (30:70, v/v) as a mobile phase with a flow rate of 1 mL/min and UV detection at 220 nm. Results Good linear relationships were obtained within the ranges 1–10 µg/band and 2–10 µg/mL for TLC–densitometry and HPLC, respectively. The obtained results were statistically compared with those of the official HPLC method and showed no significant difference with respect to their accuracy and precision at P = 0.05. Greenness scores represent excellent green analysis results in comparison with the reported studies. Conclusions The proposed methods were validated according to ICH guidelines and were applied on bulk powder and pharmaceutical dosage forms using eco-friendly mobile phases in line with worldwide trends. Highlights Chromatographic methods have been validated for the estimation of MDF in the presence of its degradation product. Clarification of the degradation pathway and elucidation of the structure were stated for the first time. This is the first published method using greenness assessment metrics for the analysis of MDF.

中文翻译：

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使用分析生态量表估计莫达非尼的两种经过验证的稳定性指示色谱方法的绿色评估

背景莫达非尼 (MDF) 是用于治疗发作性睡病的药物之一。目的 本手稿描述了 MDF 在其酸诱导降解产物存在下的两种色谱稳定性指示方法的开发和验证。方法 在不同的应力条件下降解中密度纤维板，并利用红外光谱和质谱对降解产物进行鉴定。第一种方法涉及 TLC，其中使用预涂有硅胶 G60 F254 的板，显影系统是二氯甲烷-甲醇 (9:1, v/v)。第二种方法是使用 C-18 色谱柱和乙醇-H2O (30:70, v/v) 作为流动相的环保 (HPLC) 方法，流速为 1 mL/min，UV 检测温度为 220纳米。结果 TLC-光密度法和 HPLC 分别在 1–10 µg/波段和 2–10 µg/mL 范围内获得了良好的线性关系。所得结果与官方 HPLC 方法的结果进行统计学比较，在 P = 0.05 时其准确度和精密度无显着差异。与报告的研究相比，绿色度得分代表了出色的绿色分析结果。结论 所提出的方法已根据 ICH 指南进行了验证，并适用于使用环保流动相的散装粉末和药物剂型，符合全球趋势。亮点 色谱方法已经过验证，可用于估计存在降解产物的 MDF。首次阐明降解途径和阐明结构。