HPLC法测定阿法替尼片的含量

Determination of Afatinib Tablets by HPLC

目的：建立高效液相色谱法测定阿法替尼片含量的方法。方法采用Phenomenex Luna C18色谱柱（4.6 mm ×250 mm，5μm），流动相为0.02 mol·L-1磷酸二氢钾（2 mol·L-1氢氧化钠溶液调pH 6.0）-乙腈（50：50），柱温为30℃，检测波长为252 nm，流速为1.0 mL·min-1。结果阿法替尼浓度在20~120μg·mL-1范围内线性关系（r＝0.9999）良好，平均回收率为100.3%，RSD为0.93%。结论本方法专属强，准确度高，简便，快速。

Objective To establish an HPLC method for the determination of Afatinib Tablets. Methods A stable HPLC method was established,and the chromatography was accomplished on Phenomenex Luna C18 column（4. 6 mm ＆#215; 250 mm,5 μm）,the mobile phase consisted of 0. 02 mol·L-1 of potassium dihydrogen phosphate（ adjusted to pH 6. 0 with 2 mol·L-1 sodium hydroxide solution）-acetonitrile（ 50：50 ）,the column temperature was 30 ℃,the detection wavelength was 252 nm and the flow rate was 1. 0 mL·min-1. Results The linear range of afatinib was 20~120 μg·mL-1（r=0. 999 9）,the average recovery was 100. 3% with corresponding RSD of 0. 93%. Conclusion The method was specific,ac-curate,convenient and rapid.