Abstract: ObjectiveTo establish the dissolution method of atorvastatin calcium tablets. MethodsColumn Agilent TC-C18(4.6×250 mm, 5μm) with mobile phase consisted of acetonitrile: tetrahydrofuran: 0.05 M ammonium citrate buffer pH 4.0 (27:20:53) at a flow rate of 1.5 mL·min-1 when the detective wavelength was set at 244 nm, plus the atorvastatin and atorvastatin related compound H peak area to calculate the cumulative release amount(%); ResultsAtorvastatin calcium was instable in pH 1.0 hydrochloric acid solution and acetic acid- ammonium acetate buffer (pH 4.5) and degrade to atorvastatin related compound H, the pH 1.0 hydrochloric acid solution dissolution profile of atorvastatin calcium tablets was the slowest one. ConclusionThe pH 1.0 hydrochloric acid solution dissolution profile of atorvastatin calcium tablets can be used as the basis for formulation screening.

Key words: atorvastatin calcium, atorvastatin related compound H, dissolution, cumulative release amount (%), correction factor