采用手性固定相高效液相色谱法拆分沙库巴曲钙的手性异构体

Isomer Separation of Sacubitril Calcium on a Chiral Column Using High Performance Liquid Chromatography

目的:建立高效液相色谱法拆分沙库巴曲钙手性异构体的方法。方法:采用高效液相色谱法,色谱柱(CHIRALCEL OJ-RH,4.6 mm×150 mm,5μm);以0.1%三氟乙酸-水为流动相A,以0.1%三氟乙酸-乙腈为流动相B,进行梯度洗脱;流速为0.7 mL/min;检测波长为254 nm;柱温为25℃。结果:该方法经过专属性、检测限、定量限、溶液稳定性和重复性的验证。结论:该方法可定量检测沙库巴曲钙的三个手性异构体含量。

Objective:To establish a high performance liquid chromatography method for the separation of chiral isomers of sacubitril calcium.METHODS:HPLC was performed on a Chiralcel OJ-RH column(4.6 mm×150 mm,5μm).The gradient elution was carried out using 0.1%trifluoroacetic acid-water as mobile phase A and 0.1%trifluoroacetic acid-acetonitrile as mobile phase B.The flow rate was 0.7 mL/min.The detection wavelength was 254 nm.The column temperature was 25℃.Results:The method was verified by specificity,limit of detection,limit of quantification,solution stability and reproducibility.Conclusion:The method can be used to quantitatively determine the content of three chiral isomers of sacubitril calcium.