建立了高效液相色谱法同时测定依那普利非洛地平缓释片中的5个特定杂质(依那普利拉、依那普利双酮、非洛地平杂质A、B和C)。采用Agilent Zorbax SB-Phenyl色谱柱,以0.02 mol/L磷酸二氢钠缓冲液(用磷酸调至pH 2.0)∶甲醇为流动相,梯度洗脱,检测波长215 nm。结果显示主成分与各特定杂质峰均能有效分离,各特定杂质均在0.5~20μg/ml范围内线性关系良好,检测限分别为0.13、0.24、0.11、0.15和0.19μg/ml,平均回收率分别为101.7%、99.3%、101.5%、98.7%和98.5%,RSD分别为1.52%、0.63%、1.29%、3.16%和2.06%。 A high performance liquid chromatographic method was developed for the simultaneous determination of five specific impurities (enalapril, enalapril dione, felodipine Impurity A, B, and C) in the enalapril felodipine extended release tablets. An Agilent Zorbax SB-Phenyl column was used with 0.02 mol / L sodium dihydrogen phosphate buffer (adjusted to pH 2.0 with phosphoric acid): methanol as mobile phase and gradient elution with a detection wavelength of 215 nm. The results showed that the main components and each impurity peak can be effectively separated, the specific impurities in the range of 0.5 ~ 20μg / ml good linearity, the detection limits were 0.13,0.24,0.11,0.15 and 0.19μg / ml, the average recovery Respectively, which were 101.7%, 99.3%, 101.5%, 98.7% and 98.5%, respectively, with RSDs of 1.52%, 0.63%, 1.29%, 3.16% and 2.06%, respectively.