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

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 µg/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 µg/ml and 0.0957 µg/ml for Ezetimibe and for that of Rosuvastatin the LOD and LOQ values were found to be 0.0291 µg/ml and 0.0892 µg/ml for respectively. Stress degradation studies were performed and the method was validated as per ICH guidelines.