HPLC法测定胸腺五肽及其有关杂质

Determination of thymopentin and its related impurities

目的:建立具有普适性的高效液相色谱法测定胸腺五肽及相关杂质。方法:采用 Kromasil-C_(18)柱(4.6 mm×250 mm,5 μm),流动相为40 mmol·L^(-1)磷酸二氢钠缓冲液(pH 3.75)-甲醇(85:15),流速:1 mL·min^(-1),检测波长:210 nm。结果:线性范围为1.66～212.4 μg·mL^(-1),r=0.9998,最低检测限量为10 ng,本方法重复性和精密度良好(RSD<2%)。结论:采用HPLC 法可测定不同合成工艺合成的胸腺五肽粗肽、成品及其有关杂质,方法简便,结果准确。

Objective：To establish HPLC method for determination of thymopentin （TP -5） and its related impurities. Methods：Kromasil - C18 column（4.6 mm ×250 mm,5 μm） was used; The mobile phase was 40 mmol· L^-1 Nail2 PO4 （ pH 3.75 ） - methanol （85： 15 ） at a flow rate of 1.0 mL·min^-1. TP - 5 was eluted with the same solvent. The detection wavelength was 210 nm. Results：There was a good relationship with the range of 1.66 -212. 4μg· mL^-1（ r = 0. 9998 ）. The repeatability and precision of the method were good （RSD 〈 2% ）. Conclusion：The method to determine the content and the related impurities of TP -5 by HPLC is simple and accurate.