A new stability indicating RP-UFLC method for the simultaneous estimation of Ezetimibe and Rosuvastatin combined dosage forms (Tablets)

Abstract

The combination of Ezetimibe and Rosuvastatin is used for lowering the cholesterol along with proper diet. A new stability indicating RP-UFLC method has been developed and validated for the estimation of Ezetimibe and Rosuvastatin in tablet dosage forms. Shimadzu Model CBM-20A/20 Alite UFLC system with Phenomenex C18 column (PDA detector) was used for the present chromatographic study. Both the drugs obeyed Beer-Lambert’s law over the concentration range 0.1-150 mg/ml and the linear regression equations are found to be y = 43364x + 8195.5 and y = 49468x – 7194 (R² = 0.9999) (R² = 0.9999) Ezetimibe and Rosuvastatin respectively. The LOD and LOQ values were found to be 0.0287 mg/ml and 0.0957 mg/ml for Ezetimibe and for that of Rosuvastatin the LOD and LOQ values were found to be 0.0291 mg/ml and 0.0892 mg/ml for respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines.