高效液相色谱法测定他米巴罗汀胶囊的含量

Assay of tamibarotene capsule by HPLC

目的建立他米巴罗汀胶囊含量测定方法。方法采用高效液相色谱法（HPLC）进行测定,色谱柱为CEC-C8柱（150 mm×4.6 mm,5μm）,流动相为乙腈-0.1%磷酸-甲醇（1∶1∶1）,检测波长为235 nm。结果他米巴罗汀在2.51~40.12μg/mL浓度范围内,峰面积与浓度呈良好的线性关系,r=0.999 9;重复性试验的RSD为0.12%（n=6）,最低检测限为0.2 ng,平均回收率为99.60%,他米巴罗汀主峰与辅料有良好分离。结论此法简单、灵敏、专属性强、重现性好,结果准确可靠,适用于他米巴罗汀胶囊的质量控制。

Purpose To establish HPLC method for assay of tamibarotene capsule.Methods The sample of tamibarotene was determined by HPLC on the CEC-Cs column（150 mm×4.6 mm,5 μm）.Results The standard curve of tamibarotene was linear in the range of 2.51-40.12 μg/mL,r=0.999 9,the RSD of repeatability test was 0.12%（n=6）,the LOD was 0.2 ng,the average recovery was 99.60% and its RSD was 0.57%.The resolution between tamibarotene and excipient was good.Conclusion The method is simple,sensitive,accurate and reliable,which is an effective method for the determination of tamibarotene capsules.