摘要
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。
Aim To establish an RP-HPLC method for the determination of cilnidipine related substances.Methods The separation was performed on octadecylsilane chemically boned silica column.The mobile phase was composed of acetonitrile∶0.025 mol·L-1ammonium 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 calibration 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.
出处
《安徽医药》
CAS
2011年第10期1224-1226,共3页
Anhui Medical and Pharmaceutical Journal
