期刊论文

Determination of dacomitinib and related substances by HPLC

Zhao, L.

中文

中国新药杂志

1003-3734

2020

29

7

822-825

10.3969/j.issn.1003-3734.2020.07.018

本校为第一且通讯机构

目的:建立测定达克替尼含量及有关物质的高效液相色谱法(high performance liquid chromatography, HPLC),以控制达克替尼的质量标准。方法:采用Agilent Eclipse XDB×C_(18)柱(250 mm×4.6 mm, 5 μm);流动相为乙酸铵水溶液(30 mmol·L~(-1))-甲醇(20∶80);流速: 1.0 mL·min~(-1);柱温为25 ℃;检测波长为252 nm;进样体积为20 μL。结果:本方法能较好地分离达克替尼和杂质峰,达克替尼浓度在48.40~242.0 μg·mL~(-1)浓度范围内,线性关系良好(r= 0.999 9);精密度、稳定性、重复性的RSD均

Objective: To establish a high performance liquid chromatography (HPLC) method for the determination of dacomitinib and related substances for the purpose of quality control of dacomitinib. Methods: The determination was performed on the Agilent Eclipse XDB×C18 column (250 mm×4.6 mm, 5 μm) with the mobile phase consisted of ammonium acetate solution (30 mmol•L-1)-methanol (20:80) at a flow rate of 1.0 mL•min-1. The column temperature was set at 25℃, the detection wave length was set at 252 nm, and the injection size was at 20 μL. Results...