HPLC测定HX0969w原料药的含量及有关物质

Determination of HX0969w and its related substances by HPLC

目的测定HX0969w原料药的含量及有关物质。方法采用线性梯度洗脱法,色谱柱为Agilent Zorbax XDB C18柱(150 mm×4.6 mm,5μm),流动相A为0.5%的碳酸氢铵,流动相B为乙腈,流速1 mL.min-1,检测波长260 nm。结果HX0969w和丙泊酚的线性范围分别为:1227.0～19.2μg.mL-1(r=0.9999)、97.7～3.1μg.mL-1(r=0.9998);日内RSD分别为0.17%、0.20%;日间RSD分别为0.33%、0.42%。结论所用方法简便、准确,适用于HX0969w原料药的含量测定及有关物质的检查。

OBJECTIVE To establish a method to determine the content of HX0969w and its related substances.METHODS Linear gradient elution was adopted with Agilent Zorbax XDB C18 column（150 mm×4.6 mm,5 μm）,UV detection at 260 nm,and the mobile phase consisted of 0.5% ammonium bicarbonate-acetonitrile.The flow rate was 1.0 mL·min^-1.RESULTS The calibration curve of HX0969w was linear within the range of 1227.0-19.2 μg·mL-1（r=0.9999）.The calibration curve of propofol was linear within the range of 97.7-3.1 μg·mL-1（r=0.9998）.The Intra-day precision for this analysis of HX0969w and propofol were 0.17% and 0.20% respectively.The Inter-day precision of HX0969w and propofol were 0.33% and 0.42%,respectively.CONCLUSION The method is simple,accurate and effective for the quality control of HX0969w and its related substances.