HPLC法测定阿法替尼片中主药和有关物质的含量  

Quantitative determination of main component and related substances in afatinib tablets by HPLC

作　　者：李赫宇 赵玲[2] 

机构地区：[1]天津市益倍建生物技术有限公司,天津300457 [2]武汉轻工大学生物与制药工程学院,武汉430023

出　　处：《天津药学》2016年第4期22-24,30,共4页Tianjin Pharmacy

摘　　要：目的：建立以高效液相色谱法测定阿法替尼片中主药和有关物质含量的方法，以控制该制剂的质量。方法：色谱柱为KromasilC18（250mm×4．6mm，5μm），流动相为乙酸铵水溶液（30mmol／L）-甲醇（25：75），流速为1．0ml／min，紫外检测波长为254nm，柱温30℃，进样量为20μl。结果：阿法替尼检测浓度的线性范围为60．13～600．45μg/ml（r=0．9996）；平均回收率为99．41％，RSD为0．86％。结论：建立的检测方法简单，结果准确可靠，可用于阿法替尼片的质量控制。Objective： To establish an HPLC method for the determination of the main component and related substances in afa- tinib tablets. Methods： The determination was performed on Kormasil CIS column （250 mm ×4.6 mm, 5 μm） with mobile phase composed of ammonium acetate solution（ 30 retool/L） -methanol（25： 75） at a flow rate of 1.0 mL/min. The detection wavelength was set at 254 nm at 30 ℃. The injection size was at 20 μl. Results： The calibration curve of afatinib was linear in the range of 60.13 - 600.45μg/ml （ n = 5, r = 0. 999 6 ） , and the average recovery of afatinib was 99.41% （ RSD was 0.86% ）. Conclusions ： This method is rapid, accurate and reliable, and applicable for the quality control of afatinib tablets.

关 键 词：阿法替尼 含量测定 高效液相色谱法 有关物质 

分 类 号：R927.2[医药卫生—药学]