摘要
目的:建立测定吉非替尼分散片中主药含量的方法。方法:采用反相高效液相色谱法。色谱柱为Diamonsil C18(2),流动相为乙腈-0.015%三氟乙酸(26:74,三乙胺调pH值为3.9),流速为1.0mL.min-1,检测波长为344nm,柱温为30℃。结果:吉非替尼检测浓度线性范围为0.08～6.05μg.mL-1(r=0.9998);平均回收率为100.55%,RSD=1.28%(n=9)。结论:该方法操作简便、快速、重复性好,可用于吉非替尼分散片的含量测定。
OBJECTIVE： To establish the method for the content determination of main component in Gefitinib dispersible tablet. METHODS： RP-HPLC method was adopted. The separation was achieved by Diamonsil C18 （2） column using acetoni- trile-0.015% trifluoroacetic acid （26：74, pH adjusted to 3.9 with triethanolamine） as mobile phase at the flow rate of 1.0 mL.min-t. The detection wavelength was set at 344 nm and the column temperature was 30 ℃. RESULTS： The linear range of gefitinib was 0.08-6.05 μg.mL-1 （r=0.999 8） with an average recovery of 100.55% （RSD=1.28%, n=9）. CONCLUSION： The method is simple, rapid and reproducible, and it is suitable for the content determination in Gefitinib dispersible tablet.
出处
《中国药房》
CAS
CSCD
2012年第13期1225-1226,共2页
China Pharmacy
