梯度洗脱HPLC法测定盐酸厄洛替尼片的含量  

Content Determination of Erlotinib Tablets by HPLC with Gradient Elution

作　　者：张宇佳 相莉 陈少华 郑稳生 

机构地区：[1]中国医学科学院、北京协和医学院药物研究所,药物传输技术及新型制剂北京市重点实验室,北京100050

出　　处：《中国药房》2014年第45期4282-4284,共3页China Pharmacy

基　　金：“重大新药创制”科技重大专项课题资助项目(No.2009ZX09301-003)

摘　　要：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5~300μg/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。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.

关 键 词：盐酸厄洛替尼片 含量测定 高效液相色谱法 杂质 

分 类 号：R927.2[医药卫生—药学]