A high-performance thin-layer chromatographic method was developed and validated for the concurrent determination of simeprevir (SMV) and sofosbuvir (SOF). The chromatographic separation was attained on silica gel 60 F254 as stationary phase and ethyl acetate–hexane–methanol (5.0:4.0:1.0, v/v/v) as developing solvent with UV detection at 273 nm. The RF values were 0.67±0.02 and 0.43±0.02 for SMV and SOF, respectively. The method has been validated in respect to the guidelines of the International Conference on Harmonization. Linearity was maintained between 60–1,000 and 70–1,200 ng/band for SMV and SOF, respectively, with good correlation coefficients (0.9993–0.9997) for both drugs. The suggested method was highly sensitive as the calculated detection limits were 15 and 22 ng/band, while the quantitation limits were 44 and 66 ng/ band for SMV and SOF, respectively. The suggested methodology has been effectively employed for the determination of the mentioned drugs in their pure forms and their pharmaceutical dosage forms as well as human plasma without significant interference of the pharmaceutical excipients or plasma components.

中文翻译：

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同时测定两种丙型肝炎抗病毒药物 Sofosbuvir 和 Simeprevir 的可行 TLC-光谱-密度测定技术：在联合药物剂型和人血浆中的应用

开发并验证了一种高效的薄层色谱方法，用于同时测定西美瑞韦 (SMV) 和索非布韦 (SOF)。色谱分离采用硅胶 60 F254 作为固定相，乙酸乙酯-己烷-甲醇（5.0:4.0:1.0, v/v/v）作为展开溶剂，紫外检测波长为 273 nm。SMV 和 SOF 的 RF 值分别为 0.67±0.02 和 0.43±0.02。该方法已根据国际协调会议的指南进行了验证。SMV 和 SOF 的线性分别保持在 60–1,000 和 70–1,200 ng/波段之间，两种药物的相关系数都很好 (0.9993–0.9997)。建议的方法高度灵敏，因为计算出的检测限为 15 和 22 ng/波段，而 SMV 和 SOF 的定量限分别为 44 和 66 ng/条带。所建议的方法已被有效地用于测定纯形式和药物剂型以及人血浆中提到的药物，而不会显着干扰药物赋形剂或血浆成分。