HPLC法测定阿戈美拉汀原料药的有关物质

Determination of Agomelatine related substances by HPLC

目的:采用HPLC法测定阿戈美拉汀原料药的有关物质。方法:采用Symmtry C18(4.6 mm×250 mm,5μm)色谱柱;流动相A为乙腈:10 mmol磷酸氢二钠(磷酸调节pH至3.5)=30∶70;流动相B为乙腈,梯度洗脱;流速为1.0 mL/min;检测波长为230 nm;柱温为35℃。结果:阿戈美拉汀及其已知杂质(杂质1、杂质2、杂质3和杂质4)的线性范围分别为0.05～1.2μg;平均回收率分别为104.6%、101.3%、104.9%、99.6%;结论:本法简便、准确、适合于阿戈美拉汀原料药有关物质测定。

Objective： To establish an HPLC method to determination related substances of Agomelatine. Methods： The analytical column was Symmtry C18 （4.6 mm× 250 mm, 5 μm） column. The mobile phase A was composed of acetonitrile and 10 mmol/L disodium hydrogen phosphate （with phosphoric acid pH=3.5） （30 ： 70）, mobile phase B was acetonitrile ,gradient elution; at a flow rate of 1.0 ml/min. The wavelength of UV detector was 230 nm and column temperature was 35 ℃. Results： The linear ranges of Agomelatine and impurities were 0.05-1.2 μg, the average recovery was 104.6 %, 101.3 %, 104.9 %, 99.6 %; Conclusion： This method is convenient and accurate to determine the related substances of Agomelatine.