The invention discloses a method for determining
impurity content in a
hydrocortisone acetate intermediate 2 by utilizing HPLC (
High Performance Liquid Chromatography), and belongs to the technical field of pharmaceutical analysis. According to the method, a
chromatographic column taking octadecyl bonded
silica gel as a filler is adopted, water is taken as a mobile phase A,
acetonitrile is taken as a mobile phase B,
gradient elution is carried out, and the content of impurities in
hydrocortisone acetate
bromide is measured. According to the method disclosed by the invention, the
hydrocortisone acetate intermediate 2 can be well separated from impurities, the
spectral purity of a destroyed sample is greater than 990 through peak purity detection under various conditions, and the detection specificity of related substances is good; meanwhile, when the chromatographic condition parameters are slightly changed, the separation and inspection results of main components and impurities are not influenced, and the durability is good; according to the method, the related substances in the
hydrocortisone acetate intermediate 2 can be rapidly, effectively, accurately and reliably separated and detected, the product quality of the
hydrocortisone acetate intermediate 2 is improved, and the medication safety of a patient is improved.