Gusarova V, Vorobjeva T, Gusarov D, Lasman V, Bayramashvili D
Experimental Biotechnological Plant, Shemyakin-Ovchinnikov Institute of Bioorganic Chemistry of Russian Academy of Sciences, Mikloukho-Maklaya Street, 16/10, Moscow 117997, Russian Federation.
J Chromatogr A. 2007 Dec 28;1176(1-2):157-62. doi: 10.1016/j.chroma.2007.10.090. Epub 2007 Nov 4.
Size-exclusion chromatography based on silica-diol sorbent was employed to analyze the recombinant proinsulin fusion protein obtained during the process of refolding and the following ion-exchange purification. The assay was qualified as a control method estimating its accuracy, precision, linearity, limit of detection, limits of quantitation, specificity, and robustness. The results show the reliability for the intended use.
采用基于二醇基硅胶吸附剂的尺寸排阻色谱法，对重折叠及后续离子交换纯化过程中获得的重组胰岛素原融合蛋白进行分析。该测定方法被认定为一种对照方法，评估了其准确性、精密度、线性、检测限、定量限、特异性和稳健性。结果表明该方法对于预期用途具有可靠性。
