摘要
目的 高效液相色谱法测定达沙替尼原料药的含量及其有关物质。方法 采用YMC Pack Pro C18色谱柱,以流动相A〔50mM醋酸铵溶液pH 5.25∶乙腈∶甲醇(90∶5∶5)〕和流动相B〔50mM醋酸铵溶液pH 5.25∶乙腈∶甲醇(10∶85∶5)〕进行梯度洗脱,流速为1.2mL.min-1,检测波长为320nm,柱温为35℃,进样体积10uL。结果 在选定的色谱条件下,样品和各中间体分离度良好;在5～50μg.mL-1范围内线性关系良好,最低检测线为0.015μg.mL-1。结论 所用方法灵敏、准确、可靠。
OBJECTIVE To establish a method for determination of dasatinib and related substances by HPLC. METHODS The chromatography was carried out with YMC Pack Pro C18 column. Gradient elution,mobile phase A ammonium acetate solution （50mM, pH 5.25） ： acetonitrile： methanol = 90： 5： 5 ; mobile phase B ammonium acetate solution （50mM,pH 5.25） ： acetonitrile： methanol = 10：85：5. The flow rate was 1.2mL· min^-1 ,the detection wavelength was 320nm,the column temperature was 35℃ and the injection volume was 10uL RESULTS Under the selected chromatographic condition, the sample could separated well with the three intermediates. The calibration curve for Dasatinib was linear in the range of 5 -50μg·mL^-1. The detection limit for Dasatinib was 0. 015μg·mL^-1. CONCLUSION The method is svecific, simvle, sensitive and can be used for quality control of Dasatinib.
出处
《海峡药学》
2013年第7期72-74,共3页
Strait Pharmaceutical Journal
