梯度洗脱HPLC法测定盐酸厄洛替尼片的含量

目的:建立测定盐酸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Kromasil C18,流动相为30 mmol/L乙酸铵-乙腈,梯度洗脱,流速为1.0 ml/min,检测波长为342 nm,柱温为60℃,进样量为10μl。另将本法与同条件下流动相等度洗脱法进行比较。结果:盐酸厄洛替尼检测质量浓度线性范围为5³00μg/ml(r=0.999 9),平均回收率为100.27%(RSD=0.11%,n=3)。在等度色谱条件下,只检出1个杂质峰;在梯度条件下,检出3个杂质峰,且各峰间分离较好。结论:建立的方法灵敏、准确、可靠,可用于盐酸厄洛替尼片的含量测定。

Content Determination of Erlotinib Tablets by HPLC with Gradient Elution

OBJECTIVE ： To establish the method for the content determination of Erlotinib tablets. METHODS ： HPLC method was adopted. The determination was performed on a Kromasil C18 column,with mobile phase consisted of 30 mmol/L ammonium acetate-acetonitrile at the flow rate of 1.0 ml/min by gradient elution. The detective wavelength was set at 342 nm, the sample size was 10 μl and the column temperature was 60℃. The separate effects were compared between the isocratic elution and gradient elution.RESULTS： The linear rang of erlotinib was 5-300 μg/ml（r=0.999 9） with an average recovery of 100.27% （RSD=0.11%, n=3）.Only one impurity peak was detected under the condition of isocratic gradient, but 3 impurity peaks were detected under the condition of gradient elution and with good separation among each peak. CONCLUSIONS： The method is sensitive , accurate, and reliable.It can be applied for the content determination of Erlotinib tablets.