The invention relates to the technical field of pharmaceutical analysis, and particularly discloses a method for detecting related substances in lodoxamide
tromethamine. According to the invention, chromatographic conditions are optimized, a C18 column with
hybrid particles charged on the surface is used as a
chromatographic column,
gradient elution is carried out under a specific mobile phase, and a
high performance liquid chromatography capable of effectively separating lodoxamide
tromethamine from nine related substances is provided, and the related substances comprise INT1, INT2, LODT-A, LODT-B, LODT-C, LODT-D, LODT-E, LODT-F and LODT-G. Through methodological research and
verification of specificity, sensitivity and the like, the detection method for the impurities in lodoxamide
tromethamine provided by the invention is high in sensitivity and accuracy, and relatively good in reproducibility and durability, each
impurity peak does not interfere with a main peak, each chromatographic peak can be well separated, and the detection method is suitable for large-scale industrial production. And a reliable guarantee is provided for better controlling the quality of the lodoxamide tromethamine product.