| 引用本文: | 李沿飞,朱琳,陶凌晖,蒋文,苏敏.HPLC测定合成胸腺肽α1原料药和有关物质含量[J].中国现代应用药学,2010,27(3):265-268. |
| .HPLC Determination of Contents and Related Substances of Synthetic Thymosin α1[J].Chin J Mod Appl Pharm(中国现代应用药学),2010,27(3):265-268. |
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| 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。 |
| 关键词: 胸腺肽α1 高效液相色谱法 |
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| HPLC Determination of Contents and Related Substances of Synthetic Thymosin α1 |
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LI Yanfei1 ZHU Lin2 TAO Linghui2 JIANG Wen2 SU Min2*
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| 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. |
| Key words: thymosin α1 HPLC |
