高效液相色谱法测定药片中吉非替尼的含量

Determination of Gefitinib in Tablets by HPLC

目的:研究高效液相色谱法测定药片中吉非替尼的含量。方法:根据高效液相色谱法,设定好色谱柱和流动相后,将波长、流速设定为330nm与1.0ml/min,将柱温作为室温,以甲醇作为色谱纯,溶剂均为分析纯。结果:检测结果表明,吉非替尼保持10～100μg/ml浓度范围可以和峰面积线性保持良好的关系。经实验检测得出精密度较好,可以重复检测,而且平均加样回收率较高。结论:高效液相色谱法检测操作简单便,而且快速准确,通过检测吉非替尼含量,能更好的控制吉非替尼质量。

Objective: To study the determination of gefitinib in tablets by high performance liquid chromatography. Method : According to high performance liquid chromatography, set the column and mobile phase, set the wavelength, flow rate to 330nm and 1. 0mL/min, the column temperature as room temperature, methanol as the chromatographic purity, the solvents are all analytically pure. Results :The results showed that the range of 10-100 pg/ml gefitinib maintained a good linear relationship with the peak area. The experimental test shows that the precision is better, and the test can be repeated, and the average recovery rate is high. Conclusion: HPLC detection is simple, rapid and accurate. By measuring gefitinib content, it can better control the quality of gefitinib.