BILAYER TABLET OF ROSUVASTATIN CALCIUM AND FENOFIBRATE: AN ASSESSMENT PRIOR TO FORMULATION DESIGN

Lokesh Kumar Bhati* and M. Vijay Kumar

ABSTRACT

A simple, specific and accurate HPLC method was developed for the estimation of Rosuvastatin Calcium (RSTCa) and Fenofibrate (FB) in combination. The separation of two drugs using steel column 25 cm x 4.6 mm packed with octadecylsilane bonded to porous silica (5 μm ),with mobile phase containing Acetonitrile: Methanol: phosphoric acid (50:25:25v/v) was used and eluents were monitored at 286nm. The retention times of RSTCa and FB were 2.45±0.03 and 5.856±0.03min, respectively and both the drugs showed good linearity with a correlation coefficient (R) of 0.9999 and 0.9997 for RSTCa and FB, respectively. The proposed methods have been successfully applied to pharmaceutical formulation and were validated according to ICH guidelines and method showed good precision with percent relative standard deviation less than 2%. The proposed method was accurate and precise for the HPLC estimation of RSTCa and FB in bulk and pharmaceutical dosage forms.

Keywords: Rosuvastatin Calcium, Fenofibrate, HPLC estimation, Validation, precision.