HPLC法测定二甲苯磺酸拉帕替尼片中拉帕替尼的含量

摘要

OBJECTIVE: To establish a method for the content determination of lapatinib in Lapatinib ditosylate tablets. METHODS: HPLC method was adopted. The separation was performed on Kromasil C18 column with mobile phase consisted of 0.01 mol· L-1 K2HPO4 buffer-methanol (20:80) at the flow rate of 1.0 mL·min-1. The detection wavelength was set at 262 nm and the injection volume was 20 μL. RESULTS: The linear range of lapatinib was 20.14～181.3 μg·mL-1 (r=0.999 9)with an average recovery of 99.35% (RSD=0.38%). CONCLUSION: The method is simple, rapid, accurate and reliable, and it is applicable for the quality control of Lapatinib ditosylate tablets.%目的:建立测定二甲苯磺酸拉帕替尼(LD)片中拉帕替尼含量的方法.方法:采用高效液相色谱法.色谱柱为Kromasil C18,流动相为0.01 mol·L-1 K2HPO4缓冲液-甲醇(20:80),流速为1.0 mL·min-1,检测波长为262 nm,进样量为20 μL.结果:拉帕替尼检测浓度的线性范围为20.14～181.3 μg·mL-1(r=0.9999);平均回收率为99.35％ (RSD =0.38％).结论:本方法操作简便快捷,结果准确可靠,可用于LD片的质量控制.