反相高效液相色谱法测定丁酸氯维地平及有关物质

Determination of Levidipine and Related Substance by RP-HPLC

目的：建立丁酸氯维地平及其有关物质的反相高效液相色谱分析方法。方法使用 Welchrom C18（250 mm×4.6 mm,5μm）色谱柱,以甲醇-乙醇-水（40：20：40）为流动相,以流速1 mL·min^－1洗脱,柱温45℃,检测波长240 nm。结果丁酸氯维地平与各杂质及中间体能完全分离,在151.00-604.00 ng·mL^－1范围内线性关系良好（r ＝0.9992）,回归方程为 Y＝0.0499X＋0.5979。最小检出浓度31.9 ng·mL^－1。结论该方法专属性强,灵敏度高,操作简单,分析速度快,适用于丁酸氯维地平的有关物质检查。

Objective To develop a reversed phase high performance liquid chromatography （ RP-HPLC） method determining the related substances and levidipine. Methods The Welchrom C18 column （250 mm×4.6 mm,5 μm） was used with Octadecylsilane bonded silica as a filler.The mobile phase consisted of methanol-ethanol-water （40：20：40）,at the flow rate of 1 mL·min^-1 in an isocratic elution,the temperature was at 45 ℃ , and the detective wavelength was 240 nm. Results Levidipine could be separated from all impurities and intermediates within the concentration range from151 to 604 ng·mL^-1 , which had a satisfied linear relationship （r= 0.999 9） with a regression equation of Y= 0.049 9X＋0.597 9.The LOQ of detection was 31.9 ng·mL^-1 . Conclusion The developed method is specific,sensitive,easy and fast to operate,which is suitable for detecting levidipine and its related impurities.