A NEW RP-HPLC METHOD DEVELOPMENT AND VALIDATION OF FOR THE SIMULTANEOUS ESTIMATION OF ROSUVASTATIN CALCIUM AND FENOFIBRATE IN TABLET DOSAGE FORM

In the present work, an attempt was made to provide a newer, sensitive, simple, accurate and low cost HPLC method. It is successfully applied for the determination of Rosuvastatin and Fenofibrate in pharmaceutical preparations without the interferences of other constituents in the formulations. The optimum wavelength for detection was 256 nm at which better detector response for drug was obtained. The average retention time for Rosuvastatin and Fenofibrate was found to be 2.006 and 3.856 min respectively. System suitability tests are an integral part of chromatographic method. They are used to verify the reproducibility of the chromatographic system. To ascertain its effectiveness, system suitability tests were carried out on freshly prepared stock solutions. The calibration was linear in concentration range of 10 ? 50 μg/ml and160-800 μg/ml with regression 0.999 and 0.999, for Rosuvastatin and Fenofibrate respectively. The low values of % R.S.D. indicate that method is precise and accurate. Sample to sample precision and accuracy were evaluated using six samples of same concentration and three samples each of three different concentrations respectively, which were prepared and analyzed on same day. The mean recovery values obtained were between 99 and 100.5 % confirming accuracy of the proposed method. There is no interference due to placebo at the retention time of analyte. Hence the method is specific. Keywords: Rosuvastatin , Fenofibrate, chromatographic, LOD, LOQ.