1,1-环己基二乙酸单酰胺及相关物质的高效液相色谱分析

Study on the Analysis of Related substance of 1,1-Cyclohexane diacetic Acid Monoamide by HPLC

目的:应用高效液相色谱法对1,1-环己基二乙酸单酰胺(CAM)及相关物质进行分析测定,建立CAM及相关物质的分析方法[1]。方法:采用Agilent(4.6×250mm)SB-C18为分析柱,磷酸水溶液:乙腈=(70:30)为流动相(pH=1.90),流速1.0mL/min,柱温40℃,检测波长210nm。结果:CAM与相关物质分离良好,线性范围分别是CAM:60.184～3.0092×106ng(R=0.9990),CDA:2.0072×102～2.0072×105ng(R=1),CDI:2.012～4.024×103ng(R=0.9989)。结论:该方法简便、快速、分离度高,适合于CAM及相关物质的测定。

Objective： To establish an analytical method for the 1,1-Cyclohexane diacetic Acid Monoamide （ CAM）by HPLC.Methods： The analytical column was AgilentSB-C18 （4.6×250mm） with detective wavelength at 210nm.The mobile phase consisted of acetonitrile-phosphoric acid water solution （30：70）（pH=1.90） with flow rate of 1.0mL/min and column temperature at 40℃. Results： CAM was separated with its related substances efficiently. The linear ranges of three substances were CAM：60.184-3.0092×10^6ng （R=0.9990）, CDA：2.0072×10^2-2.0072×10^5ng （R=I）,CDI：2.012-4.024×10^3ng （R=0.9989）. Conclusion： The method was proved to be simple, rapid and accurate. It is suitable for determination of CAM and its related substances.