Aim To establish an RP-HPLC method for the determination of cilnidipine related suhstances. Methods The separation was performed on octadecylsilane chemically honed silica column. The mobile phase was composed of acetonitrile:0. 025 mol · L-1 ammonium dihydrogen phosphate solution: cyclohexane( 60∶39∶ 1 ). Column temperature was 40℃ , and the flow rate was 1. 5 ml · min -1 . The detection was carried out with UV detector at 240 nm. Results Through intensity destructive test under this detection,main peak and impurity peak were well separated.with not being disturbed. Specificity calihration curves were linear within 1 ～ 16 mg · L-1( r = 0. 999 992 ). RSD was 0. 42％ ( n = 6 ). Conclusion The test shows that this method is suitable for the determination of cilnidipine related substances.%目的 建立西尼地平有关物质检测方法.方法 采用十八烷基硅烷键合硅胶柱,流动相为乙腈:0.025 mol·L-1磷酸二氢铵溶液:环己烷=60:39:1,柱温40℃,流速1.5 ml·min-1,检测波长为240 nm.结果 通过破坏性试验,用此条件检测,主峰和杂质峰均能很好的得到分离,不受干扰,专属性强,线性范围:1～16 mg·L-1(r=0.999 992),RSD为0.42%(n=6).结论 该方法能够检测出西尼地平中的有关物质.
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