HPLC法测定甲磺酸伊马替尼片的含量

Determination of Imatinib Mesylate Tablets by HPLC

目的建立高效液相色谱法测定甲磺酸伊马替尼片含量的方法。方法色谱柱为Kromasil C18(4.6 mm×250mm,5μm),以含0.04%辛烷磺酸钠的20 mmol.L-1磷酸二氢钠溶液(磷酸调至pH 2.5)-甲醇(40:60)为流动相,流速为1.0 mL.min-1,检测波长为268 nm,柱温为30℃。结果甲磺酸伊马替尼在25.055～501.1μg.mL-1浓度范围内线性关系良好,r=0.999 9;RSD均小于2%;加样回收率在99.54%～101.23%之间。结论该方法准确、简便、快速,可用于甲磺酸伊马替尼片的含量测定。

Objective To establish an HPLC method for the determination of Imatinib Mesylate Tablets. Methods Kromsil C is column（ 4.6 mm × 250 ram,5 μm）was adopted with 20 mmol· L^-1 sodium dihydrogen phosphate containing 0.04% octane sulfonic acid sodium salt（ adjusted pH to 2.5 with H3PO4） -methanol（40： 60）as the mobile phase at the flow rate of 1.0 mL · min^-1. The detection wavelength was 268 nm. The column temperature was 30 ℃. Results The imatinib mesylate showed a good linear relationship within the range of 25. 055 - 501.1μg · mL^- 1 ,r = 0. 999 9. All the RSD were less than 2%. The average recoveries were 99.54% - 101.23%. Conclusion This method was accurate,simple and rapid,and it can be used for the determination of Imatinib Mesylate Tablets.