文档介绍：HPLC法测定注射用胸腺肽α1的含量
(作者:___________单位: ___________邮编: ___________)
【摘要】目的:改进注射用胸腺肽α1含量测定的方法。方法:色谱柱为Luna C18( 5μm ,×250mm);()乙腈(92∶8),流动相B为乙腈,梯度洗脱, mL/min ;检测波长为210nm;柱温为室温;进样量20μL。结果:~ 范围内具有良好的线性关系,r = ,%。结论:改进后的方法操作简单,省时,重复性好,进一步完善了产品的质量标准。
【关键词】高效液相色谱法;注射用胸腺肽α1;含量测定
[ABSTRACT] Objective: To improve the content determination method for thymopetidum α1 injection. Methods:Content of 20μL thymopetidum injection was determined by high performance liquid chromatography (HPLC) instrument fixed with a Luna C18 (5 μm , mm×250mm). The mobile phase A was water with mol/L KDP () and AN(92∶8), mobile phase B was AN, and gradient elution was used. The flow rate was 1.
0 mL/min, detective wavelength was 210 nm and column temperature was room temperature. Results:The linear range for content of thymopetidum α1 injection was ~ mg/mL, r=, the average recovery was %. Conclusion:The improved determination method is simple, timesaving with good repeatability, and can help to improve the quality standards of injective thymopetidum.

[KEY WORDS]High performance liquid chromatography (HPLC);Thymopetidum α1 injection;Content determination
注射用胸腺肽α1主要成分为胸腺肽α1,是化学合成的28肽,临床用于慢性乙型肝炎和作为免疫损害病者的疫苗免疫应答增强剂。在2010年版中国药典二部中收录的注射用胸腺肽α1标准[1]和国家食品药品监督管理局颁布的药品试行标准(YBH26822005)中规定的含量测定方法,梯度洗脱时间较长,操作繁琐且重复性