Abstract

Validated stability indicating RP-HPLC method development for the assay of Rosuvastatin in pure and formulations

Author(s): B.Koteswara Rao, M.Nageswara Rao, G.Ramu, C.Rambabu

A simple, precise, accurate and rapid isocratic reverse phase liquid chromatographic method was developed for the determination of Rosuvastatin in pure and pharmaceutical formulations.Waters (Alliance) HPLC System equipped with Empower Software-2 software is adopted for the present investigation. Thermo hypersil BDS, C18 (150mmX4.6mm, 5µparticle size) columnmaintained at a temperature of 30°C, a mobile phase of potassium di hydrogen phosphate buffer and acetonitrile in the ratio 40: 60maintained at a flow rate of 0.8ml per minute were chosen for the analysis. The components were detected at 243nm using UV-detector.About 20 µL of standard and sample solutionwere injected, the chromatogramswere obtained under the optimized chromatographic conditions and system suitable parameters were found to be satisfactory. Retention time, peak area and tailing factor of the standard peak were found to be 3.086 min, 4231231 and 1.17 respectively. The detector response was found to be linear over the range of concentration 5-30µg/mL. A study of forced degradation was carried out in different degradants and the percent of degradation was found be 2.62- 5.62. The pharmaceutical formulations were analyzed and percentage of assay was found to be 99.88. The proposed method may be used as an alternative method in quality control in any pharmaceutical industry.