Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Menoufia University, Menoufia, Egypt.
Department of Analytical Chemistry, Faculty of Pharmacy, Minia University, Minia 61519, Egypt.
J Chromatogr Sci. 2021 May 20;59(6):576-583. doi: 10.1093/chromsci/bmab034.
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.
建立并验证了一种用于同时测定西米普韦（SMV）和索非布韦（SOF）的高效薄层色谱法。色谱分离在硅胶 60 F254 上作为固定相，以乙酸乙酯-正己烷-甲醇（5.0:4.0:1.0，v/v/v）作为展开溶剂，在 273nm 处进行紫外检测。SMV 和 SOF 的 RF 值分别为 0.67±0.02 和 0.43±0.02。该方法已按照《国际协调会议》的指导原则进行了验证。SMV 和 SOF 的线性范围分别为 60-1000 和 70-1200ng/band，两种药物的相关系数均良好（0.9993-0.9997）。该方法具有较高的灵敏度，计算得到的检测限分别为 15 和 22ng/band，定量限分别为 44 和 66ng/band。该方法已有效地用于测定两种药物的纯品及其制剂以及人血浆中的药物，药物赋形剂或血浆成分无明显干扰。
