Abstract: ObjectiveTo establish the dissolution method of rosuvastatin calcium tablets. MethodsColumn: Agilent Extend C18 (4.6×250 mm, 5 μm), eluted with acetonitrile and 0.02% TFA in gradient mode. The ratio of acetonitrile kept 37% in 13 min and increased to 90% from 13~27 min at a flow rate of 1.0 mL·min-1 when the detective wavelength was set at 242 nm, plus the rosuvastatin and (3S, 5S)-rosuvastatin calcium peak area to calculate the cumulative release amount (%). ResultsRosuvastatin calcium was instabile in pH 1.0 hydrochloric acid solution and degraded to (3S, 5S)-rosuvastatin calcium, rosuvastatin-5S-lactone and rosuvastatin-5R-lactone, when treated with alkali and regenerated to rosuvastatin and (3S, 5S)-Rosuvastatin calcium, also the dissolution profile of rosuvastatin calcium tablets in pH1.0 hydrochloric acid solution was the slowest one. ConclusionThe dissolution profile of rosuvastatin calcium tablets in pH 1.0 hydrochloric acid solution can be used as the basis for formulation screening.

Key words: rosuvastatin calcium, (3S, 5S)-rosuvastatin calcium, dissolution, cumulative release amount (%), correction factor