摘要
目的建立测定丁酸氯维地平原料药中有关物质的RP-HPLC法。方法采用Welchrom C（18）色谱柱（250 mm×4.6 mm,5μm）;流动相为甲醇–环己烷–水（70∶0.5∶30）;体积流量为1 m L/min;柱温为30℃;检测波长为240 nm;进样体积为20μL。结果丁酸氯维地平及其14种杂质能够达到良好的分离;丁酸氯维地平及其杂质I、III、IV、V的质量浓度与峰面积的线性关系良好;丁酸氯维地平及其14种杂质的检测限（S/N≥3）在0.57~3.13 ng。结论该方法简便准确、重复性好,专属性强,精密度高,可用于丁酸氯维地平原料药中有关物质的测定。
Objective To establish an RP-HPLC method for determination of related substances in clevidipine butyrate bulks drug. Methods The separation was performed on a Welchrom C（18） column（250 mm × 4.6 mm, 5 μm） with methanol- cyclohexane- water（70∶0.5∶30） as mobile phase. The detection wavelength was set at 240 nm and the injection volume was 20 μL at the flow rate of 1.0 m L/min. The column temperature was 30 ℃. Results Clevidipine butyrate and 14 kinds of its impurities could be achieved good separation. There were good linear relationships of clevidipine butyrate and impurity I, III, IV, and V between concentration and peak, and the detection limits（S/N ≥ 3） were 0.57 — 3.13 ng. Conclusion This method is simple, accurate, reproducible, specific, and suitable for the determination of related substances in clevidipine butyrate bulks drug.
出处
《现代药物与临床》
CAS
2015年第12期1446-1450,共5页
Drugs & Clinic
