Novel Analytical Method Development and Validation for Estimation of Clinical Important Rosuvastatin in Bulk and Pharmaceutical Dosage Form by UV Spectroscopy Method Using Phosphate Buffer Solubility

Author(s): Suvarna G. Bhokare* and R.P. Marathe

Biosynthesis of cholesterol is a natural phenomenon and gets completed in lever in 25 steps. Disorderin any of the steps may cause over or under production of cholesterol that may lead ultimately to atherosclerosis, thrombosis or coronary artery disease, depending on disorder. Statins are the class of drugs that inhibit HMG CoA reductase, a rate limiting enzyme, competitively during mevalonate pathway in the synthesis of cholesterol in hepatocytes. Rosuvastatinis a synthetic drug of this class. It is newer drug with 20% bioavailability and 19 hours elimination half-life. Like other statins it principally reduces total cholesterol (Hypercholesterolemia), LDL choles-terol(Hyperlipoproteinemia), triglycerides (Hypertriglyceridemia), lipids (Dyslipidemia) and increases HDL choles-terol (Hypolipoprteinemia) to cure atherosclerosis, thrombosis and coronary artery disease. A rapid, specific and economic UV spectrophotometric method has been developed to determine the rosuvastatin content in bulk and pharmaceutical dosage formulations. At a pre-determinedabsorption maximaof 246nm in phosphate buffer at pH 7.4, it was proved linear in the range of 10-150μg/ml and exhibited good correlation coefficient (R2=0.983) and excel-lent mean recovery (98.12% to 103.54%). This method was successfully applied to the determination of rosuvastatin and validated statistically as per recommended guideline of ICH for recovery studies, linearity, precision, repeata-bility, and reproducibility. The obtained results proved that the method can be employed for the routine analysis of rosuvastatin in bulks as well as in the commercial formulations.


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