A NEW STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD 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 reproducible stability indicating RP- HPLC method.. 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 ?g/ml and160-800 ?g/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. The drugs were subjected to stress conditions such as acid hydrolysis, alkali hydrolysis, oxidative and thermal degradation as per ICH guidelines. The present method can be successfully used for routine quality control and stability studies. Keywords: Rosuvastatin , Fenofibrate, chromatographic, ICH, Forced degradation.