多肽化合物MLA有关物质测定方法研究

Study on the determination method for the related substances of peptide MLA

目的:建立多肽化合物MLA有关物质可靠的测定方法。方法:通过高效液相色谱对流动相、色谱柱、梯度、柱温、波长等不同条件摸索,优化最佳检测方法。结果:试验最终选择条件IV,用安捷伦Zorbax 300 SB-C18色谱柱,柱温选择25℃,检测波长选择220 nm进行测试,并验证了该检测方法的专属性。结论:本实验条件建立的MLA有关物质的测定方法稳定可靠,各杂质能够较好分离,不会干扰测定。

Objective:To establish a reliable method for the determination of the related substances of peptide MLA.Methods:The best detection methods are optimized by high performance liquid chromatography on different conditions such as mobile phase,column,gradient,column temperature and wavelength.Results:Condition IV is selected and carried out using an Agilent Zorbax 300 SB-C18 column with a column temperature of 25℃and the detection wavelength of 220 nm.The specificity of the test method is verified.Conclusion:The method for determining MLA-related substances established under the experimental conditions is stable and reliable,the impurities can be separated well without interference,and will not interfere with the measurement.