Determining method of atorvastatin calcium related substance

Abstract

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.

Description

Technical field: [0001] The invention relates to a method for determining drug impurities, in particular to a method for determining the content of atorvastatin calcium-related substances by HPLC. Background technique: [0002] Atorvastatin calcium, usually in the form of trihydrate, has the following chemical formula: [0003] [0004] The chemical name is: [R-(R*,R*,)]-2-(4-fluorophenyl)-(.(-dihydroxy-5-(1-methylethyl)-3-phenyl- Calcium 4-[(aniline)carbonyl]-1-hydro-pyrrole-1-heptanoate trihydrate [0005] This product is white or off-white crystalline powder; odorless, bitter taste. [0006] This product is easily soluble in methanol, slightly soluble in ethanol or acetone, very slightly soluble in water, almost insoluble or insoluble in chloroform and ether. [0007] Its identification method is as follows: [0008] Get this product, add methanol to make a solution containing about 120g in every 1ml, measure according to spectrophotometry (Chinese Pharmacopoeia 19...

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Problems solved by technology

[0028] The present invention finds through research that the impurity B of the prior art is difficult to separate, and the impurity E is difficult to detect and separate, and the quality of the product cannot be controlled by using the prior art. For this reason, the inventor has studied the detection method and found a method for the above-mentioned Determination method with good impurity separation, high precision and small error

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