Abstract

DEVELOPMENT AND VALIDATION OF NEW RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF ROSUVASTATIN AND FENOFIBRATE IN PURE AND PHARMACEUTICAL FORMULATIONS

Yaganti Vineela*, S. V. U. M. Prasad and D. Vinay Kumar

ABSTRACT

A simple, Accurate, precise method was developed for the simultaneous estimation of the Rosuvastatin and Fenofibrate in Tablet dosage form. Chromatogram was run through X- Bridge C18 150 x 4.6 mm, 3.5. Mobile phase containing Buffer Potassium dihyrogen orthophosphate: Acetonitrile taken in the ratio 35:65 was pumped through column at a flow rate of 1.2 ml/min. Buffer used in this method was 0.1% ortho phosphoric acid buffer. Temperature was maintained at 25°C. Optimized wavelength selected was 238 nm. Retention time of Rosuvastatin and Fenofibrate were found to be 1.95 min and 3.85 min. %RSD of the Rosuvastatin and Fenofibrate were and found to be less than 2 respectively and are with in the limits. %Recovery was obtained as 97.58-99.10% and 98.03-98.05% for Rosuvastatin and Fenofibrate respectively. LOD, LOQ values obtained from regression equations of Rosuvastatin and Fenofibrate were 0.018, 0.05 and 0.06, 0.19 respectively. Regression equation of Rosuvastatin is y = 112536x + 7467.8 and y = 157892x + 16980 of Fenofibrate. Retention times were decreased and run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Keywords: Rosuvastatin, Fenofibrate, RP-HPLC, Simultaneous estimation, Validation as per ICH guidelines, LOD,LOQ.