摘要
目的：采用HPLC法测定盐酸埃克替尼乳膏含量及有关物质。方法：含量测定采用Grace C18色谱柱（250 mm×4.6 mm,5μm）,流动相为0.02 mol·L-1磷酸二氢钠溶液-乙腈（50∶50）,流速为1.0 m L·min-1,检测波长为334 nm。有关物质检测采用Grace C18色谱柱（250 mm×4.6 mm,5μm）,0.1 mol·L-1磷酸二氢钠溶液-乙腈（60∶40）为流动相,检测波长为246 nm,流速为1.0 m L·min-1。结果：盐酸埃克替尼在4.01~40.10μg·m L-1范围内具有良好的线性关系（A=51 863C-11 321,r2=0.999 7）,重复性良好（RSD=1.46%）。进样精密度、重复性良好。平均回收率为99.15%,RSD值为0.58%。空白辅料不干扰检测,盐酸埃克替尼与相关杂质之间的分离度良好。结论：本方法可以方便、快速、准确地检测盐酸埃克替尼乳膏的含量及其有关物质。
Objective： To develop high performance liquid chromatography（ HPLC） methods for the determination of icotinib hydrochloride and its related substances. Methods： Grace C18column（ 250 mm × 4. 6 mm,5 μm） was used for the determination of Icotinib Hydrochloride. The mobile phase was 0. 02 mol·L- 1sodium dihydrogen phosphate buffer-acetonitrile（ 50∶ 50） with the flow rate set at 1. 0 m L·min- 1. The detection wavelength was 334 nm. Grace C18column（ 250 mm × 4. 6 mm,5 μm） was used for detecting the related substances. The mobile phase was 0. 1 mol·L- 1sodium dihydrogen phosphate buffer-acetonitrile（ 60∶ 40） with the flow rate set at 1. 0 m L·min- 1. The detection wavelength was 246 nm. Results： The calibration curve of Icotinib Hydrochloride was linear in the range of 4. 01 ~ 40. 10 μg·m L- 1（ A = 51 863C- 11 321,r2= 0. 999 7）. Repeatability was good（ RSD =0. 24%）. Icotinib hydrochloride and its related substances were completely separated. Conclusion： The established methods possess the characteristics of specificity,easy operating,accuracy and good reproducibility,and can be employed to determine the content and related substances of icotinib hydrochloride.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2015年第21期2516-2520,共5页
Chinese Journal of New Drugs
