梯度洗脱HPLC法测定甲磺酸伊马替尼含量及有关物质  

Determination of imatinib mesylate and related substances by gradient elution HPLC

作　　者：王棋[1] 宋锐[1] 费梦莹[1] 严拯宇[1,2] 

机构地区：[1]中国药科大学分析化学教研室,南京211198 [2]中国药科大学药物质量与安全预警教育部重点实验室,南京211198

出　　处：《海峡药学》2012年第3期58-60,共3页Strait Pharmaceutical Journal

摘　　要：目的建立甲磺酸伊马替尼原料药含量测定和有关物质检查方法。方法采用Herdera C18(5μm,4.6mm×250mm)色谱柱,甲醇-辛烷磺酸钠水溶液,梯度洗脱,流速为1mL.min-1,检测波长为267nm,进样体积为20μL,柱温为40℃。结果在选定色谱条件下,主要合成的中间体和各降解产物可以完全分离。线性范围8.12～81.20μg.L-1(r=0.9999),检测限为0.02μg.mL-1。结论所用方法准确、灵敏、可靠。OBJECTIVE A method for determination of Imatinib mesylate and related substances was established.METHODS The liquid chromatography was carried out using a Herdera C18（5μm,4.6mm×250mm）column.The mobile phase consisted of methanol-solution of 1-octanesulfonic acid sodium salt（36mmol·L-1）,gradient elution.The flow rate was 1mL·min-1.The detection wavelength was 278nm.The injection volume was 20μL.The column temperature was 40℃.RESULTS The intermediates and degraded substances could be separated.Three batches of sample were determined.The calibration curve for Imatinib mesylate was linear in the range of 8~80μg·L-1（r=0.9999）.The detection limit for Imatinib mesylate was 0.02μg·mL-1.CONCLUSION The method is specific,accurate,sensitive,simple,and can be used for quality control of Imatinib mesylate.

关 键 词：甲磺酸伊马替尼 有关物质 含量测定 HPLC 

分 类 号：R927.11[医药卫生—药学]