高效液相色谱法测定甲磺酸伊马替尼片的含量

目的：建立高效液相色谱法测定甲磺酸伊马替尼片的含量。方法采用 Waters Symmetry C18（150×4.6mm，3.5μm）为固定相；流动相为0.05mol· L －1KH2PO4溶液（pH＝3.0）∶乙腈＝77∶23（v／v）；检测波长为235nm；流速为1.0mL· min －1；进样体积为20μL；柱温40℃。结果本方法在0.0814mg· mL －1～0.1322mg· mL－1浓度范围内，呈现良好的线性关系（r＝0.9995）；重复性和日间精密度良好，其相对标准偏差（ RSD）分别为0.39％和0.36％；平均回收率为99.5％。结论本方法简便、快速、准确，可用于甲磺酸伊马替尼片的含量测定。

Determination of Imatinib Mesylate Tablets by High Performance Liquid Chromatography

ABSTRACT:OBJECTIVE To establish a high performance liquid chromatography method for determination of Imatinib mesylate tablets.METHODS The liquid chromatography was carried out by using a Waters Symmetry C18 (3.5μm,150 ×4.6mm) as column.The mobile phase was 0.05mol· L-1KH2PO4 solution(adjust to pH 3.0 with H3PO4)∶acetonitrile=77∶23(v/v).The detection wavelength was set at 235nm;the flow rate was 1.0mL· min-1 and the injection volume was 20μL.The column temperature was 40℃.RESULTS A good linear relationship was acquired ranging from 0.0814mg· mL-1 to 0.1322mg· mL-1 ,and the correlation coefficient ( r) was 0.9950.The method showed good reproducibility and intermediate precision,and the relatively standard deviation ( RSD) of which were 0.39%and 0.36%respectively.The average recovery was 99.5%.CONCLUSION The method is sample, fast and accurate for determining the content of Imatinib mesylate tablets.