摘要
建立西洛他唑分散片有关物质的检测方法.采用C_8柱(250 mm×4.6 mm,5μm);流动相A为乙腈-水(25∶75),流动相B为乙腈-水(50∶50);梯度洗脱:0―6 min―10 min―40 min,流动相A∶B的比例为100∶0―50∶50―0∶100―0∶100;检测波长254 nm.结果表明,西洛他唑与各已知杂质及降解产物均良好分离,最低检测限与最低定量限分别为0.1 ng与0.2 ng,精密度良好.本方法操作简单,对西洛他唑分散片有关物质检测快速,准确,专属性强,灵敏度高.
To establish a method for cilostazol dispersible tablets relative materials,the determinations were carried out on a C_8column（250 mm × 4. 6 mm,5 μm） with acetonitrile：water（ flow phase A） 25 ∶ 75- acetonitrile∶ water（ flow phase B） 50 ∶ 50 as mobile phase;gradient elution： 0 min ― 6 min ― 10 min ― 40 min,the ratio of phase A∶ phase B was 100∶ 0 ― 50∶ 50 ― 0∶ 100 ― 0∶ 100. The detection UV wavelength was 254 nm. The results indicated that the developed method could be used for the determination of cilostazol impurities and its metabilite with a good resolution. The limit of detection and limit of quantification of cilostazol were 0. 1 ng and 0. 2 ng,respectively. The method was proved to be simple,accurate,reproducible and feasible,and can be used for the quality control of cilostazol dispersible tablets.
出处
《哈尔滨商业大学学报（自然科学版）》
CAS
2016年第2期157-160,共4页
Journal of Harbin University of Commerce：Natural Sciences Edition
