摘要
目的:运用高效液相色谱方法测定胸腺五肽原料药中醋酸及三氟醋酸的残留量。方法:采用大连依利特ODSC18-BP(5μm4.6×250mm)色谱柱;pH3.0磷酸盐缓冲液及甲醇为流动相,进行梯度洗脱;流速为1.0mL·min-1;检测波长210nm;柱温为25℃。结果:该方法中醋酸和三氟醋酸的分离度符合要求;醋酸的最低检测限10.5ng,三氟乙酸最低检测限14.8ng;样品中未检出醋酸和三氟醋酸残留。结论:该方法可行,对胸腺五肽的质量控制有一定的意义。
Objective：To establish an HPLC gradient test method of HAc and TFA residual in Thymopentin material.Method：The HPLC was carried out with Kromasil ODS CIS-BP（5μm4.6×250mm）column set at 25℃.The mobile phase was methanol and phosphoric acid pH3.0 with flow rate of 1.0mL.min-I The detection wavelength was set at 210nm.Results：The Resolution between HAc and TFA is acceptable;LOD of HAc and TFA are respective 10.5ng and 14,Sng;HAc and TFA are not detected at Thymopentin material,Conclusion：The proposed method is suitable for determination of HAc and TFA of Thymopentin material.
出处
《医学信息（中旬刊）》
2010年第4期946-947,共2页
Medical Information Operations Sciences Fascicule
