This invention discloses a method for determining
ceftazidime and its formulation polymers, comprising the following steps: 1) preparing a
system suitability solution; 2) preparing a reference solution; 3) preparing a
test solution for
ceftazidime for injection; 4) determination: injecting the
system suitability solution, reference solution, and
test solution into a liquid chromatograph, respectively, and performing determination using reversed-phase
chromatography, wherein the mobile phase of the reversed-phase
chromatography contains mobile phase A and mobile phase B, mobile phase A being an aqueous
formic acid solution and mobile phase B being
methanol. The chromatogram obtained by the method of this invention has a stable baseline, can detect multiple polymeric impurities of
ceftazidime, and exhibits good separation of each
impurity; the method of this invention has good specificity and
system suitability, and its
linearity, sensitivity,
repeatability, intermediate precision, and robustness are all good; furthermore, the
test solution and reference solution of this invention have high stability.