反相高效液相色谱法测定重组人肿瘤坏死因子衍生物

RP-HPLC Determination of Recombination Human Tumor Necrosis Factor Derivative

用正交试验法选择确定了反相高效液相色谱法分离测定ｒｈ－ＴＮＦ的条件，并在此条件下对３个厂家的７批产品进行了纯度测定，结果表明本法简便、准确、快速、选择性高。同时本文还确定了测定产品比例色谱的条件，测定了ｒｈ－ＴＮＦ比例色谱峰高，为产品鉴别提供了更为可靠的方法。

A reversed-phase high performance liquid chromatographic method was developed for the determination of rh TNF derivative using VYDAC PROTEIN C 4 column.The optional conditions for determination of rh TNF purity were selected by orthogonal design test.The peak purity was identified by ratio chromatography.The method is simple with good reproducibility with RSD<2%.