abstract |
The invention provides an analysis and detection method for simultaneous determination of enalapril maleate and folic acid and its related substances. The high performance liquid chromatograph uses octanyl-bonded silica gel as a filler and a phosphate with pH of 2.0-3.0. Buffer solution and acetonitrile were used as mobile phases, gradient elution was carried out, the detection wavelength was 210nm-220nm, and the column temperature was 40℃-60℃. The invention adopts gradient elution to realize the effective separation of various impurities, the separation degree of each absorption peak is more than 5, the injection precision is good, the RSD is less than 1%, the method has good durability, and the system applicability and solution stability are good. |