摘要
目的:建立高效液相色谱法测定甲磺酸伊马替尼片有关物质的方法。方法:色谱柱为KromasilCl8(250mm×4.6mm,5肛m),以含0.04%辛烷磺酸钠的20mmol/L磷酸二氢钠溶液(磷酸调至PH2.5)-甲醇为流动相,梯度洗脱,流速为1ml.min-1,检测波长为268nm,柱温为30℃。结果:在本方法中,甲磺酸伊马替尼的线性关系良好,r为0.9999;专属性强,甲磺酸伊马替尼与各中间体及各降解产物之间都能完全分离;精密度良好,RSD为1%。结论:该方法准确、简便、灵敏,可用于甲磺酸伊马替尼片有关物质测定。
Objective To establish a method for the related substances of Imatinib Mesylate tablets by HPLC.Methods The determination was carried out on Kromsil C18 column, with 20 mmol/L sodium dihydrogen phosphate containing 0.04% octane sulfonic acid sodium salt (adjusted PH to 2.5 with H3PO4)-methanol as the mobile phase at the flow rate of 1.0ml?min-1 ,gradient elution.The detection wavelength was 268nm. The temperature of column was 30℃ .Results The method showed good linearity with a correlation coefficient (r) of 0.9999;the specificity study showed satisfactory resolution between imatinib mesylate,other intermediates and degradation products;the precision was satisfactory with RSD 1%. Conclusion This method is an accurate,sensitive and simple method for the related substances of imatinib mesylate tablets.
出处
《中国化工贸易》
2013年第7期279-280,共2页
CHINA CHEMICAL TRADE