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目的:建立群多普利(Trandolapril)原料药含量测定方法。方法:含量检查方法采用苯基柱Ph-3(Inertsil,250mm*4.6mm,5u),选用乙腈-水(0.02mol/L磷酸二氢钾,磷酸调pH至2.7)(48:52)作流动相,检测波长220nm。含量测定采用酸碱滴定法和高效液相色谱法。结果:在建立的色谱条件下,各种降解产物均能与群多普利主峰分开,方法专属性强,滴定法与HPLC法含量测定结果无显著性差异。结论:建立得HPLC方法可用来对群多普利原料药进行含量测定,由于本品属于原料药,最终含量测定方法采用滴定法。
Objective: To establish a method for the determination of Trandolapril. Methods: The contents of phenylpropyl Ph-3 (Inertsil, 250mm * 4.6mm, 5u) were used for the determination of content. Acetonitrile-water (0.02mol / L potassium dihydrogen phosphate and phosphoric acid was added to adjust pH to 2.7) (48:52) Phase, detection wavelength 220nm. Determination of acid-base titration and high performance liquid chromatography. Results: Under the established chromatographic conditions, various degradation products could be separated from the main peak of trandolapril, and the method was very specific. There was no significant difference between titration and HPLC methods. Conclusion: The established HPLC method can be used to determine the content of trandolapril as the raw material medicine, the final determination of the content of the titration method.