The invention discloses a method for determining
allylamine in a
sevelamer carbonate medicine. The method comprises the following steps: (1) preparing a
sevelamer carbonate drug test solution and an
allylamine reference solution; (2) respectively carrying out
derivatization treatment on the
test solution and the reference solution, and during
derivatization treatment, adjusting the pH value of a
derivatization system by using a
buffer solution with the pH value of 8.4-10.8; and (3) determining the derivatization
system by using a
high performance liquid chromatography. The
sevelamer carbonate drug is alkaline, so that the pH value of a test product
reaction system is high, the pH value is greatly different from the pH value of a
reference product reaction system, the analysis result is unstable, the pH values of a test product derivative
system and a
reference product derivative system are adjusted to tend to be consistent by adding a
buffer solution, so that the influence of the pH value difference on the analysis result is reduced, and the accuracy of the analysis result is improved. The accuracy,
repeatability and stability of analysis are improved, the requirements and standards of pharmacopeia on the
analysis method are better met, and
quality control and safe production of sevelamer carbonate drugs are facilitated.