目的 制定瑞舒伐他汀鈣片溶出度的測定方法。方法 采用槳板法優(yōu)化溶出試驗(yàn)條件，紫外-可見分光光度法在241 nm處進(jìn)行吸光度測定。結(jié)果 瑞舒伐他汀鈣片溶出方法：以水900 mL（規(guī)格10、20 mg）、500 mL（規(guī)格5 mg）為溶出介質(zhì)，轉(zhuǎn)速50 r/min，30 min后取樣，照紫外-可見分光光度法在241 nm處測定。結(jié)論 建立的方法準(zhǔn)確、簡便，測定結(jié)果均一性良好，均能夠在30 min溶出完全，可有效地用于瑞舒伐他汀鈣片溶出度的測定。

Objective To establish a dissolution method for Rosuvastatin Calcium Tablets. Methods Paddle method was used to optimize the dissolution test conditions and the absorbance was measured at 241 nm by UV-visible spectrophotometer. Results The dissolution method of rosuvastatin calcium was based on water 900 mL (Size 10 mg and 20 mg) and 500 mL (size 5 mg) at the speed of 50 r/min. After 30 min the test started, the sample was measured at 241 nm according to UV-visible spectrophotometry. Conclusion The method is accurate, simple, and effective with good uniformity and capable of dissolution in 30 min for the determination of dissolution of rosuvastatin calcium in Rosuvastatin Calcium Tablets.

國家科技重大專項(xiàng)資助項(xiàng)目（2011ZX09203-002）