摘要
目的:建立测定厄洛替尼片含量的方法。方法:采用高效液相色谱法。色谱柱为PhenomexexLuna-C18,流动相为甲醇-pH3.5磷酸盐缓冲液(25:75,V/V),流速为1.0ml/min,检测波长为342nm,柱温为30℃。结果:厄洛替尼检测质量浓度线性范围为10~100μg/m(lr=0.9999),平均加样回收率为100.36%,RSD=0.62%(n=6)。结论:本方法操作简便、结果准确,可用于该制剂中厄洛替尼的含量测定。
OBJECTIVE: To establish a method for the content determination of Erlotinib tablets. METHODS: HPLC method was adopted. The determination was performed on Phenomexex Luna-Cl, column with mobile phase consisted of methanol-pH 3.5 phosphate buffer solution (25 : 75, V/V) at the flow rate of 1.0 ml/min. The detection wavelength was set at 342 nm, and the col- umn temperature was 30 ℃. RESULTS: The linear rang of erlotinib was 10-100 μg/ml (r=0.999 9) with an average recovery of 100.36% and RSD= 0.62% (n=6), CONCLUSIONS: The established method is simple and accurate. It can be applied for content determination of erlotinib in Erlotinib tablets.
出处
《中国药房》
CAS
CSCD
2013年第5期458-459,共2页
China Pharmacy