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高效液相色谱法测定他米巴罗汀胶囊的含量
引用本文:石涛,石滨,陈一辰.高效液相色谱法测定他米巴罗汀胶囊的含量[J].中国生化药物杂志,2011,32(4).
作者姓名:石涛  石滨  陈一辰
作者单位:1. 东南大学附属中大医院
2. 南京医科大学附属妇幼保健院
3. 中国药科大学,江苏南京,210009
摘    要: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。

关 键 词:他米巴罗汀  高效液相色谱  含量测定

Assay of tamibarotene capsule by HPLC
SHI Tao,SHI Bin,CHEN Yi-chen.Assay of tamibarotene capsule by HPLC[J].Chinese Journal of Biochemical Pharmaceutics,2011,32(4).
Authors:SHI Tao  SHI Bin  CHEN Yi-chen
Abstract: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.
Keywords:tamibarotene  HPLC  assay
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