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
