摘要
目的：建立奥利司他片的含量测定方法。方法：采用高效液相色谱法,Agela Venusil XBP-C18色谱柱（15cm×4.0mm,5μm）,流动相：甲醇：水：甲酸（89：11：0.1）;柱温为35℃;流速1.5mL.min-1;进样量10μL。紫外检测器,检测波长为210nm。结果：主成分奥利司他在0.40.6mg/ml浓度范围内线性关系良好,相关系数r〉0.999,平均回收率为99.4%,符合规定。结论：该方法专属性强,准确度好,可作为奥利司他片含量测定的质量控制方法。
Objective：A High performance liquid chromatography method was established to determine the contents of Orlistat Tablet.Methods：An isocratic separation was achieved by an Agela Venusil XBP-C18 C18 column at a flow rate of 1.5ml/min.The mobile phase consisted of methanol-water 89：11（v/v） spiked with 0.1 portion of formic acid.The UV detector was used at 210nm.Results：Complete separation was achieved for Orlistat and other impurities.The method was linear over the concentration range of 0.4～0.6mg/ml（r〉0.999） and the recoveries were accorded with prescribe.Conclusions：The HPLC method has the requisite accuracy and selectivity for the content determination of Orlistat Tablet.
出处
《现代生物医学进展》
CAS
2010年第22期4360-4362,共3页
Progress in Modern Biomedicine
基金
国家科技支撑计划生物医药领域课题资助项目(2008BAI67B04)
