高效液相色谱法测定来托司坦的含量及有关物质  

Determination of letosteine and its related substances by HPLC

作　　者：孙甜[1] 熊小密[1] 喻乙珊[1] 

机构地区：[1]湖北医药学院附属东风医院,十堰442008

出　　处：《西北药学杂志》2013年第2期151-153,共3页Northwest Pharmaceutical Journal

摘　　要：目的建立高效液相色谱法测定来托司坦片的含量和有关物质。方法采用Altima C18色谱柱,以乙腈-0.05mmol.L-1醋酸铵溶液(含2.5mL.L-1甲酸)(22∶78)为流动相,柱温为30℃,检测波长239nm,流速1.0mL.min-1。结果来托司坦质量浓度在5～40μg.mL-1范围内线性关系良好(r=0.999 9),最低检测限为0.2ng,回收率为99.1%。结论该方法准确、灵敏,精密度高,专属性强,可用于来托司坦的含量测定和有关物质检查。Objective To establish an RP-HPLC method for the determination of letosteine and its related substances.Method The analytical column was Altima C18 and the mobile phase was acetonitrile-0.05 mmol·L-1 ammonium acetate containing 2.5 mL·L-1 formic acid（22∶78）.The column temperature was maintained at 30 ℃.The detection wavelength was 239 nm.The flow rate was 1.0 mL·min-1.Result Letosteine was linear in the range from 5 to 40 μg·mL-1（r=0.999 9）.The limit of detection was 0.2 ng.The average recovery was 99.1%.Conclusion The method was proved to be accurate,sensitive and precise and showed highly specific.It can be applied for the content assay,as well as the related substances of letosteine.

关 键 词：高效液相色谱法 来托司坦 含量测定 有关物质 

分 类 号：R917[医药卫生—药物分析学]