Validated Spectrophotometric Method of Estimation of Rosuvastatin By Using Hydrotropic Solubilization

Abstract

Concentrated aqueous hydrotropic solutions of sodium benzoate, sodium salicylate, urea, nicotinamide, sodium citrate and sodium acetate have been observed to enhance the aqueous solubilities of many poorly water-soluble drugs. Hydrotropic solubilization involves the addition of large amount of a second solute to increase the aqueous solubility of the first solute and precludes the use of organic solvents. These hydrotropes are economic and pollution-free. In the present investigation, 1.5M Urea solution was employed as hydrotropic solubilizing agent to solubilize poorly water-soluble drug Rosuvastatin for its spectrophotometric analysis. Rosuvastatin exhibits absorption maximum at 238nm .Beer's law was found to be obeyed in the concentration range of 2-10ìg/mL. In this method, there is no interference from any common pharmaceutical additives and diluents. The correlation co-efficient ('r ' value) for Rosuvastatin was0.99955.The results of analysis have been validated as per ICH guidelines. The percentage recoveries obtained for Rosuvastatin Calcium ranges from 99.93 to 99.97 %. The method is accurate, precise and economical.