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.
出处
《西北药学杂志》
CAS
2013年第2期151-153,共3页
Northwest Pharmaceutical Journal
