NEW ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ROSUVASTATIN AND EZETIMIBE IN TABLET DOSAGE FORM

Abstract

A sensitive, specific, rugged and robust RP-HPLC method was developed for Rosuvastatin and Ezetimibe. The HPLC was of SHIMADZU 1700 having Phenomenex Gemini C18 column (150mm × 4.6 mm) 5µm particle size. The method was developed by using mobile phase containing Acetonitril, Methanol and Water in ratio of 50:10:35 having PH 3 which was adjusted by using 0.5 % o- Phosphoric acid. The Validation was carried out according to ICH guidelines. All the parameters of validation were found within acceptance criteria. The method was also applied to the marketed formulation of Rosuvastatin and Ezetimibe.