Formulation Development, Gedeon Richter Plc, Budapest X., Gyömrői út 19-21, Hungary.
J Pharm Biomed Anal. 2011 Feb 20;54(3):482-90. doi: 10.1016/j.jpba.2010.09.021. Epub 2010 Sep 19.
At present sub-2 μm packed columns are very popular to accomplish rapid and efficient separations. Applying particles with shortened diffusion path to improve the efficiency of separation performs higher efficiency than it is possible with the totally porous particles having the same size. The advantages of sub-2 μm particles and shell particles are combined in the new Kinetex 1.7 μm particles. In this study a systematical evaluation of the efficiency and achievable analysis time obtained with 5 cm long narrow bore column packed with sub-2 μm core-shell particles (1.25 μm core diameter and 0.23 μm porous silica layer), and other type very efficient columns is presented. The efficiency of separation was investigated also for small pharmaceutical and large molecules (proteins). Van Deemter, Knox and kinetic plots are calculated. The results obtained with low molecular weight polar neutral analytes (272 g/mol, 875 g/mol), with a polypeptide (4.1 kDa) and with different sized proteins (18.8 kDa, 38.9 kDa and 66.3 kDa) are presented in this study. Moreover, particle size distribution, and average pore size (low-temperature nitrogen adsorption, LTNA) of the new very fine core-shell particles were investigated. According to this study, increased flow rates can be applied on sub-2 μm core-shell columns to accomplish very fast separations without significant loss in efficiency. The new sub-2 μm shell particles offer very high efficiency both for small and large molecule separation.
目前,亚 2 微米填充柱非常流行,可实现快速高效的分离。应用缩短扩散路径的颗粒来提高分离效率比使用具有相同尺寸的全多孔颗粒可实现更高的效率。新的 Kinetex 1.7 微米颗粒结合了亚 2 微米颗粒和壳颗粒的优点。在这项研究中,系统地评估了用 5 厘米长的窄内径柱填充亚 2 微米核壳颗粒(1.25 微米核直径和 0.23 微米多孔硅层)和其他高效类型的柱获得的效率和可实现的分析时间。还研究了小药物和大分子量(蛋白质)的分离效率。计算了 Van Deemter、Knox 和动力学图。本研究中还展示了用低分子量极性中性分析物(272 g/mol、875 g/mol)、多肽(4.1 kDa)和不同大小的蛋白质(18.8 kDa、38.9 kDa 和 66.3 kDa)获得的结果。此外,还研究了新的非常细的核壳颗粒的粒径分布和平均孔径(低温氮吸附,LTNA)。根据这项研究,亚 2 微米核壳柱可以应用更高的流速来实现非常快速的分离,而不会显著降低效率。新的亚 2 微米壳颗粒在小分子和大分子分离方面都具有非常高的效率。