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 C₁₈色谱柱(250 mm×4.6 mm,5 μm);流动相为甲醇-环己烷-水(70:0.5:30);体积流量为1 mL/min;柱温为30 ℃;检测波长为240 nm;进样体积为20 μL。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 C₁₈ 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 mL/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.