HPLC法测定2-甲氧基雌二醇原料药中主药和有关物质的含量

目的:建立测定2-甲氧基雌二醇原料药中主药及有关物质含量的方法。方法:采用高效液相色谱法。色谱柱为AgilentEclipse XDB-C18;流动相为甲醇-水(65∶35),流速为1.0 mL·min-1;柱温为30℃;检测波长为285 nm。结果:2-甲氧基雌二醇与杂质分离度良好,其检测浓度线性范围为45.96～229.8μg·mL-1(r=0.999 8,n=5),检测限和定量限分别为2、10 ng;3批样品的有关物质含量均低于2.0%。结论:该方法准确、快速、分离度好、灵敏度高,可用于2-甲氧基雌二醇原料药的质量控制。

Content Determination of Main Component and Related Substances of 2-Methoxyestradiol by HPLC

OBJECTIVE： To establish a method for the content determination of 2-methoxyestradiol and its related substances. METHODS： HPLC method was adopted. Agilent Eclipse XDB-Cls column was adopted with methanol-water （65：35） as mobile phase at the flow rate of 1.0 mL.min-1. The detection wavelength was set at 285 nm and cohurm temperature was 30℃. RE- SULTS： Good separation of 2-methoxyestradiol and related substance could be achieved. The standard curve was linear in the range of 45.96--229.8 μg. mL 1（r=0.999 8, n=5）. The limit of detection and quantification was 2 ng and 10 ng respectively, and the total contents of the related substances in 3 batches samples were all below 2.0%. CONCLUSION： The method is accurate, rapid, well-separated and sensitive, and it can be used for the quality control of 2-methoxyestradiol.