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目的采用HPLC法测定马西替坦中有关物质的含量。方法色谱柱为Agela Venusil XBP C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-水(1L水中加入1.0 m L三乙胺,用磷酸调p H3),梯度洗脱,流速1 m L·min~(-1),柱温35℃,检测波长220nm,进样量10μL。结果马西替坦与11种杂质均可达到基线分离,马西替坦和各杂质的线性范围均为0.05~1.5μg·m L~(-1),重复性试验的RSD<2.0%,平均回收率的RSD<10%。结论所用方法专属性强、准确度高,可用于马西替坦中有关物质的检查。
Objective To determine the content of macitentan in HPLC by HPLC. Methods The chromatographic column was a column of Agela Venusil XBP C_ (18) (250 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-water (1.0 mL triethylamine in 1 L water and pH 3 with phosphoric acid) The flow rate was 1 m L · min -1, the column temperature was 35 ℃, the detection wavelength was 220 nm and the injection volume was 10 μL. Results Both macitentan and 11 impurities could be separated baseline. The linear range of macitentan and each impurity was 0.05 ~ 1.5 μg · m L -1, RSD of repeatability test was less than 2.0% Recovery RSD <10%. Conclusion The method used is specific and accurate, and can be used for the examination of related substances in macitentan.