HPLC法测定群多普利中有关物质

Determination of Related Substances in Trandolapril by HPLC

目的:建立HPLC法测定群多普利中的有关物质。方法:色谱柱为依利特Hypersil BDS C18柱(250 mm×4.6 mm,5μm)。流动相:甲醇-四氢呋喃-水-磷酸-二乙胺(50∶3∶50∶0.13∶0.16);流速:1.0 ml·min-1;检测波长210 nm;柱温为25℃。结果:杂质检测限分别为:(2S,3aR,7aS)-八氢-1H-吲哚-2-羧酸苄酯盐酸盐0.3 ng;SS-氢化物1.0 ng;群多普利拉4.6 ng;群多普利双酮6.0 ng。结论:所建立的方法稳定性可靠、灵敏、结果准确,可用于群多普利有关物质检查。

Objective： To establish an HPLC method for the determination of the related substances in trandolapril. Method： A Hypersil BDS C18 column（250 mm × 4.6 mm,5 μm）was used. The mobile phase was methanol-tetrahydrofuran-water-phosphoric acid- diethylamine（50： 3： 50： 0.13： 0.16） at 1.0 ml ·min-1 flow rate, and UV wavelength was set at 210 nm. The column temperature was set at 25℃. Result： The detective limit of the known impurities was 0.3, 1.0,4.6 and 6.0 ng, respectively. Conclusion： The meth- od is reliable, stable, sensitive, and can be used in the quality control of trandolapril.