HPLC法测定吉非替尼的含量Determination of Gefitinib by HPLC
曾朝晖,林明越
ZENG Chaohui,LIN Mingyue
摘要(Abstract)：
目的为控制吉非替尼原料的质量标准,建立高效液相色谱(HPLC)法测定吉非替尼原料药的含量。方法采用Phenomenex C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-醋酸铵缓冲液(40∶60,氨水调节pH 8.50±0.05),流速1.0 mL·min~(-1),检测波长247 nm,柱温40℃。结果吉非替尼与杂质峰较好分离,吉非替尼在50~400μg·mL~(-1)的范围内线性关系良好(r=0.999 8),平均回收率为99.68%,RSD=0.94%(n=9)。结论该方法操作简便、快速、重复性好,可用于吉非替尼的含量测定。
OBJECTIVE To establish an HPLC method to determine the content of gefitinib in bulk drug. METHODS HPLC was applied with Phenomenex C18column( 250 mm×4.6 mm,5 μm),the mobile phase consisted of acetonitrile-ammonium acetate buffer( 40: 60,adjust pH to 8.50±0.05 using ammonia water),the flow rate was 1.0 mL·min~(-1),the detection wavelength was 247 nm,the column temperature was 40 ℃. RESULTS The linear range of gefitinib was 50 ~ 400 μg·mL~(-1)( r= 0.999 8) and the average recovery was 99.68%,RSD = 0. 94%( n = 9). CONCLUSION This method is simple,rapid and repeatable,so it can be applicable for the content determination of gefitinib.
关键词(KeyWords)：
吉非替尼;原料药;含量测定;高效液相色谱法
gefitinib;bulk drug;content determination;HPLC
基金项目(Foundation):
作者(Author):
曾朝晖,林明越
ZENG Chaohui,LIN Mingyue
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