HPLC测定合成胸腺肽α1原料药和有关物质含量

HPLC Determination of Contents and Related Substances of Synthetic Thymosin α1

摘要: 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，Vydac C₁₈色谱柱(250 mm×4.6 mm，5 mm)；流动相：0.02 mol·L^-1磷酸盐缓冲液(pH 7.00)-异丙醇(95∶5)；柱温：25 ℃，检测波长：215 nm。结果胸腺肽α₁线性范围为0.01~0.83 mg·mL^-1 (r=0.999 8)。最低检出量为10 ng。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。

Abstract: OBJECTIVE To assay the content and related substances of thymosin α₁. METHODS　HPLC was exploited to determinate the content and related substances of thymosin a1 at 215 nm. The separation was performed on Vydac C18 column (250 mm×4.6mm，5 mm) 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.