Egyptian International Pharmaceutical Industries Co. "EIPICo.", 10th of Ramadan City, Egypt.
Pharmaceutical analytical chemistry department, Faculty of Pharmacy, Zagazig University, Zagazig, Egypt.
J Sep Sci. 2018 Apr;41(8):1734-1742. doi: 10.1002/jssc.201701263. Epub 2018 Feb 1.
The performances of core-shell 2.7 μm and fully porous sub-2 μm particles packed in narrow diameter columns were compared under the same chromatographic conditions. The stationary phases were compared for fast separation and determination of five new antiviral drugs; daclatasvir, sofosbuvir, velpatasvir, simeprevir, and ledipasvir. The gradient elution was done using ethanol as green organic modifier, which is more environmentally friendly. Although both columns provided very good resolution of the five drugs, core-shell particles had proven to be of better efficiency. Under gradient elution conditions, core-shell particles exhibited faster elution, better peak shape, and enhanced resolution adding to lower system backpressure. The column backpressure on sub-2 μm particles was more than twice that on core-shell particles. This gives a chance to use conventional high-performance liquid chromatography conditions without needing special instrumentation as that required for ultra-high performance liquid chromatography. The method was validated for determination of the five drugs by gradient elution using mobile phase composed of organic modifier ethanol and aqueous part containing 0.75 g sodium octane sufonate and 3.0 g sodium dihydrogen phosphate per liter at pH of 6.15. Detection was done using UV-detector set at 210 nm. The linearity, accuracy, and precision were found very good within the concentration range of 2-200 μg/mL.
在相同的色谱条件下，比较了核壳 2.7μm 和全多孔亚 2μm 颗粒在窄径柱中的性能。比较了固定相在快速分离和测定五种新的抗病毒药物方面的性能；达拉他韦、索非布韦、维帕他韦、西米普韦和来迪帕韦。梯度洗脱采用乙醇作为绿色有机改性剂，更环保。尽管两种色谱柱都能很好地分离这五种药物，但核壳颗粒的效率更高。在梯度洗脱条件下，核壳颗粒表现出更快的洗脱速度、更好的峰形和增强的分辨率，同时系统背压也更低。亚 2μm 颗粒的柱背压是核壳颗粒的两倍多。这使得我们有机会使用常规高效液相色谱条件，而无需像超高效液相色谱那样需要特殊仪器。该方法通过使用由有机改性剂乙醇和含有 0.75g 辛烷磺酸钠和 3.0g 磷酸二氢钠每升的水溶液组成的移动相在 pH 值为 6.15 下进行梯度洗脱来测定这五种药物。检测采用 210nm 的紫外检测器。在 2-200μg/mL 的浓度范围内，线性、准确度和精密度均很好。
