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目的采用反相HPLC法测定依折麦布片的有关物质及含量。方法采用HPLC法,色谱柱为Hypersil BDS(150mm×4.6mm,5μm);流动相为0.05mol/L磷酸二氢钾溶液-乙腈-四氢呋喃(65:25:10)等度洗脱;流速为1.0mL·min-1;柱温为30℃;检测波长为232nm。结果所采用的分析方法,能较好的分离依折麦布片的有关物质,其线性范围是98.6~295.9μg/ml(r=0.9999),最低检测限0.9ng,平均回收率为100.3%,方法精密度RSD=0.72%(n=9)。结论该方法操作简单,灵敏度高,准确可靠,可用于测定依折麦布片的含量及有关物质。
Objective To determine the related substances and contents of ezetimibe by reversed-phase HPLC. Methods The HPLC method was used. The column was Hypersil BDS (150mm × 4.6mm, 5μm). The mobile phase consisted of 0.05mol / L potassium dihydrogen phosphate solution - acetonitrile - tetrahydrofuran (65:25:10) mL · min-1; column temperature was 30 ℃; detection wavelength was 232nm. Results The analytical method adopted was better for the separation of ezetimibe-related substances with the linear range of 98.6-2995.9μg / ml (r = 0.9999), the lowest detection limit of 0.9ng and the average recovery of 100.3% The method precision RSD = 0.72% (n = 9). Conclusion The method is simple, sensitive, accurate and reliable, and can be used to determine the content of ezetimibe and related substances.