The invention relates to a determining method of an
atorvastatin calcium related substance. The method comprises the following steps of 1, preparing a
test solution, i.e. taking a proper amount of
atorvastatin calcium, adding a
solvent to dissolve and quantitatively dilute the
atorvastatin calcium until about 1mg of
atorvastatin calcium is contained in 1ml of solution, and taking the solution as the
test solution; 2, preparing a mixed reference substance solution, i.e. weighing a proper amount of reference substances of an
impurity A, an
impurity B, an
impurity C, an impurity D and an impurity E, and a proper amount of reference substance of the
atorvastatin calcium, adding the
solvent to dissolve and quantitatively dilute the reference substances until about 3 micrograms of impurity A, 2 micrograms of impurity B, 2 micrograms of impurity C, 2 micrograms of impurity D, 2 micrograms of impurity E and 10 micrograms of
atorvastatin calcium solution are contained in 1ml of solution, and taking the solution as the mixed reference substance solution; 3, performing HPLC (
High Performance Liquid Chromatography) analysis, i.e. taking 20 microliters of
test solution and 20 microliters of mixed reference substance soulution, respectively filling the test solution and the mixed reference substance into a liquid chromatograph, recording a chromatogram until a
gradient elution program is finished, and according to the
peak area of the chromatogram, calculating the content of each component.