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目的采用反相超高效液相色谱法测定比卡鲁胺中的有关物质。方法采用Acquity UPLC BEH Cl8色谱柱(50 mm×2.1 mm,1.7μm),流动相A为0.01%三氟乙酸水溶液,流动相B为0.01%三氟乙酸乙腈溶液,梯度洗脱,测定波长270 nm,流速0.5 m L·min~(-1),柱温25℃。结果各成分的分离度及检出灵敏度可满足有关物质的测定要求,0.253~5.06μg·m L~(-1)比卡鲁胺与峰面积的线性关系良好(r=0.9999)。结论所用方法专属性强、准确、简便、快速,能有效地控制比卡鲁胺的质量。
Objective To determine the related substances in bicalutamide by reversed-phase ultra performance liquid chromatography. Methods The mobile phase A was eluted with 0.01% trifluoroacetic acid in acetonitrile by mobile phase A with a mobile phase A of 0.01% trifluoroacetic acid on a mobile phase of Acquity UPLC BEH Cl8 (50 mm × 2.1 mm, 1.7 μm). The mobile phase A was eluted with a gradient of 270 nm , The flow rate was 0.5 m L · min ~ (-1) and the column temperature was 25 ℃. Results The separation and detection sensitivity of each component can meet the requirements of the determination of related substances. The linear relationship between bicalutamide peak area and 0.253 ~ 5.06μg · m L -1 was good (r = 0.9999). Conclusion The method used is specific, accurate, simple and rapid and can effectively control the quality of bicalutamide.