摘要
建立奥利司他原料药的含量测定方法。采用高效液相色谱法,Agilent SB-C18色谱柱（25cm×4.6mm,5μm）,流动相为甲醇∶水（90∶10）;柱温为30℃;流速1.0mL·min^-1;进样量20μL。紫外检测器,检测波长为190 nm。主成分奥利司他在0.4-0.6 mg/mL浓度范围内线性关系良好,相关系数r〉0.999,在相对浓度80%、100%、120%范围内的平均回收率较高。该检测方法精密度及准确度较高,可订入奥利司他原料药的质量标准中,作为含量测定的控制方法。
A high performance liquid chromatography method was established to determine the contents of orlistat substance. An isocratic separation was achieved by an agilent SB - C18 column at a flow rate of 1.0 mL/min. The mobile phase consisted of methanol - water 90： 10（v/v）. The UV detector was used at 190 nm. Complete separation was achieved for orlistat and other impurities. The method was linear over the concentration range of 0.4 - 0.6 mg/mL （ r 〉 0. 999） and the recoveries were accorded with prescribe. The HPLC method has the requisite accuracy and selectivity for the content determination of orlistat tablet.
出处
《山东化工》
CAS
2015年第11期64-65,共2页
Shandong Chemical Industry
