Abstract

METHOD DEVELOPMENT AND VALIDATION OF ROSUVASTATIN BY USING UV-SPECTROPHOTOMETRIC METHOD IN BULK AND PHARMACEUTICAL DOSAGE FORM

D. Chinababu*, SK. Aleesha, G. Bhupal Reddy, S. Pavan Kumar, P. Sudhakar, B. Varalinga Prasad and M. Parameswar Reddy

ABSTRACT

A simple, rapid and accurate UV method was developed for the determination of Rosuvastatin in bulk and pharmaceutical dosage form. The solvent system was ethanol: water in the ratio of 40:60 v/v. The wavelength was maintained at 243 nm. The method was linear over the concentration range from 0.8-16μg/mL and R2 was found to be 0.999. The intraday and interday precision %RSD values were obtained ˂ 2.0. The LOD and LOQ were attained 0.034 & 0.089μg/mL respectively. The accuracy results of the method was obtained 99.59% -99.87% at different levels of concentrations. The method was proved as robust after deliberately changed parameters of temperature and wavelength. The method was shown ability towards different stress conditions of acid & base. The method was used for routine analysis of Rosuvastatin (RST) in pharmaceutical dosage forms.

Keywords: Rosuvastatin, UV-Spectrophotometer, Ethanol.