HPLC法测定利格列汀原料药的有关物质

Determination of the Related Substance in Linagliptin by HPLC

目的采用HPLC法测定利格列汀原料药的有关物质。方法采用C18（150mm×4.6mm,5μm）色谱柱,流动相A为0.1%磷酸;流动相B为乙腈,梯度洗脱;流速为1m L·min-1,检测波长为225nm。结果利格列汀及其已知杂质（杂质A、杂质B、杂质C、杂质D、杂质E）的线性范围分别为0.05-1.2μg·m L-1;平均回收率分别为97.5%、100.2%、103.6%、97.6%和99.0%。结论本法简便、准确、可靠、适合于利格列汀原料药有关物质测定。

OBJECTIVE To establish HPLC method for quantitative determination of Linagliptin. METHODS The analytical column was Cls （150mm x 4.6mm,5txm） column. The mobile phase was composed of Acetonitrile and water （ with 0. 1% phosphoric acid ） at a flow rate of lmL · min-1 . The wavelength of UV detector was 225nm. RESULTS The linear ranges of Linagliptin. and the related substance were 0. 05 - 1.2μg ·mL-1 ,the av- erage recovery of Linagliptin was 97.5% ,100. 2% ,103.6% ,97.6% and 99.0%. CONCLUSION This method is rapid, accurate and reliable to determine the content of Linagliptin.