瑞舒伐他汀钙EP分析方法25-03.pdfVIP

© Pharmeuropa 25.3 | July 2013 147 Reference: PA/PH/Exp. P4/T (11) 36 ANP XXXX:2631 ROSUVASTATIN CALCIUM Rosuvastatinum calcicum C H CaF N O S M 1001 44 54 2 6 12 2 r [147098-20-2] DEFINITION Calcium bis[(3R,5S,6E)-7-[4-(4-fluorophenyl)-2-[methyl(methylsulfonyl)amino]-6-(propan-2- yl)pyrimidin-5-yl]-3,5-dihydroxyhept-6-enoate]. Content : 97.0 per cent to 102.0 per cent (anhydrous substance). CHARACTERS Appearance : white or almost white, hygroscopic powder. Solubility : slightly soluble in water, freely soluble in methylene chloride, practically insoluble in anhydrous ethanol. IDENTIFICATION A. Infrared absorption spectrophotometry (2.2.24). Comparison : rosuvastatin calcium CRS. B. Enantiomeric purity (see Tests). Results : the principal peak in the chromatogram obtained with the test solution is similar in retention time to the principal peak in the chromatogram obtained with reference solution (c). C. It gives reaction (b) of calcium (2.3.1). TESTS Related substances. Liquid chromatography (2.2.29). Carry out the test protected from light. Test solution. Dissolve 35.0 mg of the substance to be examined in 12 mL of acetonitrile for chromatography R and dilute to 50.0 mL with water for chromatography R. Reference solution (a). Dissolve 35.0 mg of rosuvastatin calcium CRS in 12 mL of acetonitrile for chromatography R and dilute to 50.0 mL with water for chromatography R. Reference solution (b). To 1.0 mL of the test solution add 24 mL of acetonitrile for chromatography R and dilute to 100.0