HPLC测定合成胸腺肽α_1原料药和有关物质含量

HPLC Determination of Contents and Related Substances of Synthetic Thymosin α_1

目的研究胸腺肽α1原料含量测定和有关物质考察方法。方法采用反相高效液相色谱法测定,VydacC18色谱柱(250mm×4.6mm,5μm);流动相:0.02mol·L-1磷酸盐缓冲液(pH7.00)-异丙醇(95∶5);柱温:25℃,检测波长:215nm。结果胸腺肽α1线性范围为0.01～0.83mg·mL-1(r=0.9998)。最低检出量为10ng。有关物质含量为2.5%～2.6%。结论该方法简便、可靠、准确,可用于胸腺肽α1含量测定和有关物质考察。

OBJECTIVE To assay the content and related substances of thymosin α1.METHODS HPLC was exploited to determinate the content and related substances of thymosin α1 at 215 nm.The separation was performed on Vydac C18 column（250 mm×4.6mm,5 μm） with the mobile phase of 0.02 mol·L^-1 phosphate buffer（pH 7.00）-isopropanol（95∶5） under 25 ℃ .RESULTS The linearity was obtained over the range of 0.01-0.83 mg·mL^-1（r=0.999 8）.The LOD was 10 ng.Related substances were 2.5%？2.6%.CONCLUTION The method is simple,convenient,accurate and can be employed to assay the content and related substances of thymosin α1 for its quality control.