摘要
目的建立利伐沙班的有关物质测定方法。方法采用高效液相色谱法,色谱柱为Diamonsil C8(250 mm×4.6 mm,5μm),以5 mmol/L乙酸铵溶液(含0.3%的25%四甲基氢氧化铵溶液,用冰醋酸调pH至4.8)-乙腈(80∶20)为流动相A,以5 mmol/L乙酸铵溶液(含0.3%的25%四甲基氢氧化铵溶液,用冰醋酸调pH至4.8)-乙腈(10∶90)为流动相B,梯度洗脱,检测波长为250 nm。结果利伐沙班与相邻杂质峰以及各杂质峰之间的分离度均>2.0,检测限为0.2~0.5 ng,定量限为1.0~2.0 ng。结论该方法适用于利伐沙班有关物质的测定。
Objective To establish a method to determine the related substance in Rivaroxaban.Methods HPLC method was used,column was Diamonsil C8（250 mm×4.6 mm,5 μm）,the mobile phase A was treated with 5 mmol/L ammonium acetate solution（containing 0.3% 25% tetramethyl ammonium hydroxide solution,adjusted to pH 4.8 with glacial acetic acid）-acetonitrile（80∶20）,the mobile phase B was treated with 5 mmol/L ammonium acetate solution（containing 0.3% 25%tetramethyl ammonium hydroxide solution,pH was adjusted to 4.8 with glacial acetic acid）-acetonitrile（10：90）,which was used as gradient elution The detection wavelength was 250 nm.Results The resolution of rivaroxaban and its related substance was above 2.0,detection limit was 0.2-0.5 ng,quantification limit was 1.0-2.0 ng.Conclusion The method is suitable for the determination of related substance in Rivaroxaban.
出处
《中国当代医药》
2017年第24期78-81,共4页
China Modern Medicine
