利用SEC-HPLC测定鼠神经生长因子的纯度

An Assay for Determining the Purity of Mouse Nerve Growth Fac tor by SEC-HPLC

目的：建立检测鼠神经生长因子（mNGF）纯度的分子排阻高效液相色谱法（SEC-HPLC）。方法：利用TSK G3000 SWXL分析柱和Waters 2695/2487高效液相色谱系统检测mNGF标准品纯度，并对方法的专属性、线性、重复性、中间精密度、检测限及耐用性等指标进行评估。结果：空白溶剂在mNGF积分范围内无特异峰出现；样品浓度与吸收峰之间线性回归系数R2=0.9998；6次进样峰面积相对标准偏差（RSD）为1.18%；中间精密度分析RSD为0.45%；检测限为0.2μg；耐用性实验表明磷酸盐浓度在0.2~0.3 mol/L之间变动对检测结果无影响。结论：各项指标符合规定，SEC-HPLC法可用于检测mNGF的纯度。

Objective： To develop an assay for determining the purity of mouse nerve growth factor（mNGF） by SEC-HPLC. Methods： A SEC-HPLC method was used to determine the purity of the mNGF with TSK G3000 SWXL column and HPLC system（Waters 2695/2487）. The validation for this assay was performed, including speci-ficity, linearity, repeatability, intermediate precision, limit of detection （LOD） and robustness. Results： The SEC-HPLC assay was established to determine the purity of mNGF. In this assay, the linear regression coefficient （R2） between concentration and absorption peak area was 0.9998 and the LOD of the method was 0.2 μg. Conclu-sion： The SEC-HPLC assay could be applied to determine the purity of mNGF.