The invention relates to a method for determining related substances of a compound preparation
cefprozil and
probenecid tablet, which is characterized in that the related substances are detected by
high performance liquid chromatography, the related substances are impurities in the compound preparation
cefprozil and
probenecid, and the content of the
impurity cefadroxil, other single impurities and total impurities is determined; wherein the mobile phase A is a 0.23%
ammonium dihydrogen
phosphate solution, and the mobile phase B is HPLC (
High Performance Liquid Chromatography) grade
methanol; a sample is diluted by a
diluent and then is injected, the
diluent is a
mixed solution of a 0.23%
ammonium dihydrogen
phosphate solution and HPLC-grade
methanol, the sample injection amount of the sample is 5 [mu] L, the concentration of
cefprozil is 1.5 mg / mL, and the concentration of
probenecid is 2.25 mg / ml; according to the present invention, the related substances in the cefprozil and the probenecid can be simultaneously detected, the detection cost is reduced, the method has advantages of strong specificity, high sensitivity, good reproducibility and good accuracy, has certain feasibility and practicality, is easy to popularize and apply, and can provide the research reference for the
quality control and evaluation of the product.