Industrielle Chemie: Open Access

Abstrakt

METHOD DEVELOPMENT AND VALIDATION OF ROSUVASTATIN IN BULK DRUG FORMULATION AND STRESS DEGRADATION STUDIESBY UV

Sachin Gholve, Jadhav Radha V

A simple, accurate, precise, and sensitive UV spectrophotometric method was developed for the determination of Rosuvastatin Calcium in bulk form. The optimum conditions for the analysis of the drug were established. Rosuvastatin Calcium was subjected to stress degradation under different conditions recommended by the International Conference on Harmonization (ICH). The samples so generated were used forced degradation studies using the developed method. The solvent used is ammonium acetate buffer and acetonitrile (30:70) the wavelength corresponding to maximum absorbance of the drug was found at 242 nm. Beers law was observed in the concentration range of 2-12 μg/ml with correlation coefficient 0.996. The linear regression equation obtained by least square regression method were y=0.0191X-0.0063, where y is the absorbance and x is the concentration of the pure drug solution. The limit of detection (LOD) and limit of quantitation (LOQ) for estimation of Rosuvastatin Calcium were 0.769306 μg/ml and 2.331231 μg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. The values of relative standard deviation and % recovery were found to be satisfactory, indicating that the proposed method is precise and accurate and hence can be used for the routine analysis of Rosuvastatin Calcium in bulk form.