目的 建立安立生坦片有关物质的检测方法。方法 采用高效液相梯度洗脱,色谱柱为Agela Venusil MP C₁₈柱( 4.6 mm×250 mm,5 μm),以0.02 mol·L^-1磷酸二氢钾溶液(用磷酸调节pH至3.0)-乙腈(62∶38)为流动相A、乙腈为流动相B;流速为1.0 mL·min^-1;检测波长为220 nm;柱温35 ℃。结果 在酸、碱、热、氧化破坏条件下,安立生坦产生不同程度的降解,采用建立的方法可有效检出降解产物;安立生坦与各杂质分离良好,经验证该方法的专属性、线性、耐用性等良好。结论 建立的方法可较好地分离、检测出安立生坦片中的各主要杂质,可用于本品有关物质的检查。

OBJECTIVE To establish an HPLC method for determination of the related substances of ambrisentan tablets. METHODS Gradient elution was performed on an Agela Venusil MP C₁₈ column (4.6 mm×250 mm, 5 μm). The mixture of 0.02 mol·L^-1 phosphate buffer (pH 3.0) and acetonitrile (62∶38) was used as mobile phase A, and acetonitrile as mobile phase B. The flow rate was 1.0 mL·min^-1; the detection wavelength was set at 220 nm; and the column temperature was maintained at 35 ℃.RESULTS After being treated with acid, base, heat, and oxidation, ambrisentan underwent more or less degradation. The method could effectively detect the degradation products of ambrisentan; the separation of impurities was good; the method had good specificity, linearity, and durability. CONCLUSION The proposed method can be used to separate and determine the related substances of ambrisentan tablets, and is suitable for the quality control of this drug.