阿法替尼有关物质的UPLC法测定

Determination of the Related Substances of Afatinib by UPLC

建立了超高效液相色谱法测定阿法替尼中的有关物质。使用C_(18)色谱柱,以0.05 mol/L磷酸盐缓冲液(含5 mmol/L四丁基硫酸氢铵,用磷酸调至pH 5.5)∶乙腈为流动相,线性梯度洗脱,检测波长240 nm。阿法替尼及其8个有关物质均在0.005~1μg/ml范围内线性关系良好,8个有关物质的平均回收率分别为101.3%、98.7%、102.9%、101.0%、97.7%、99.5%、100.1%和99.9%,RSD分别为1.08%、1.53%、1.04%、0.78%、1.59%、2.07%、1.91%和1.46%。本法适用于阿法替尼有关物质的检查。

An UPLC method was established for the determination of the related substances in afatinib. A C18 column was used, with the mobile phase of 0.05 mol/L phosphate buffer solution （containing 5 mmol/L tetrabutylammonium hydrogen sulfate, adjusted to pH 5.5 with phosphoric acid） ： acetonitrile by linear gradient elufion, at the detection wavelength of 240 nm. The calibration curves of afatinib and its eight related substances were linear in the range of 0.005-1 μg/ml. The recoveries of 8 related substances were 101,3%, 98.7%, 102.9%, 101,0%, 97.7%, 99.5%, 100,1% and 99.9%, with RSDs of 1.08%, 1.53%, 1.04%, 0.78%, 1.59%, 2.07%, 1.91% and 1,46%, respectively. The established method is suitable for the quality control of afatinib.