CAJ | 학술논문

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。
목적：：건립검측서신경생장인자（mNGF）순도적분자배조고효액상색보법（SEC-HPLC）。방법：이용TSK G3000 SWXL분석주화Waters 2695/2487고효액상색보계통검측mNGF표준품순도，병대방법적전속성、선성、중복성、중간정밀도、검측한급내용성등지표진행평고。결과：공백용제재mNGF적분범위내무특이봉출현；양품농도여흡수봉지간선성회귀계수R2=0.9998；6차진양봉면적상대표준편차（RSD）위1.18%；중간정밀도분석RSD위0.45%；검측한위0.2μg；내용성실험표명린산염농도재0.2~0.3 mol/L지간변동대검측결과무영향。결론：각항지표부합규정，SEC-HPLC법가용우검측mNGF적순도。
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.