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采用新型混合模式色谱柱Dionex AcclaimMixed-Mode WAX-1,建立了高效液相色谱法测定利伐沙班中的残留溶剂乙酸。流动相为乙腈∶0.025 mol/L磷酸二氢钾溶液(50∶50),检测波长为210 nm,以外标法计算。乙酸在1~10μg/ml范围内线性关系良好,平均回收率为100.6%,RSD为0.10%。
A new mixed mode column, Dionex AcclaimMixed-Mode WAX-1, was established for the determination of residual solvent acetic acid in rivaroxaban by high performance liquid chromatography. The mobile phase consisted of acetonitrile: 0.025 mol / L potassium dihydrogen phosphate solution (50:50) and the detection wavelength was 210 nm, calculated by external standard method. Acetic acid has a good linearity in the range of 1 ~ 10μg / ml with an average recovery of 100.6% and RSD of 0.10%.