Assay And Dissolution Test Method for The Analysis of Rosuvastatin Drug Dosage Forms-Pellets-15%

Abstract

Rosuvastatin chemical Name is a di hydroxy mono carboxylic acid that is (6E)-7-{4-(4-fluorophenyl)-2 [methyl (methyl sulfonyl) amino]-6-(propan-2-yl) pyrimidin-5-yl} hept-6-enoic acid.It belongs to a group of medicines called HMG-CoA reductive inhibitors, or statins.Few analytical methods are available for the analysis of Rosuvastatin active pharmaceutical ingredient(API) and formulated dosage forms like tablets and capsules even though no pharmacopoeias method is available for the pellets dosage forms. In-house U.V spectroscopic method was proposed for the analysis of assay and dissolution of ROSUVASTATIN PELLETS-15%. Apparatus USP-II (Paddle), Dissolution medium-pH 6.8 Phosphate buffer, volume1000ml, RPM-100RPM, temperature; 37.0±0.5 • C, and time: 60 minutes. The determination was accomplished by U.V Photo Spectrometer at λ (max) 282nm.Proposed method was validated according to ICH guidelines and results are within the limits and satisfactory.

Keywords: Rosuvastatin Pellets, API, USP-II, pH, RPM, U.V Spectrophoto meter, ICH, Validation