Stability Indicating Liquid Chromatographic Method for the Simultaneous Determination of Rosuvastatin and Ezetimibe in Pharmaceutical Formulations

Abstract

Purpose: A simple stability indicating reverse phase liquid chromatographic method was developed for the simultaneous determination of rosuvastatin and ezetimibe in pharmaceutical formulations. Methods: Best chromatographic response was achieved with C18 column (250 X 4.6 mm, 5μm) with photo diode array (PDA) detector. The mobile phase was composed of a mixture of sodium acetate buffer (pH 4.0) and acetonitrile (30:70, %v/v) with a flow rate of 1.2 mL/min. (UV detection at 254 nm). Rosuvastatin and ezetimibe were subjected to stress conditions of degradation and the method was validated as per ICH guidelines. Results: The method shows linearity over a concentration range of 0.5–250 μg/ml for both rosuvastatin (r2 = 0.9993) and ezetimibe (r2 = 0.9996). Both the drugs are highly sensitive towards alkaline conditions in comparison to other stress conditions. Conclusion: The proposed method can be successfully applied to perform long-term and accelerated stability studies for the simultaneous determination of rosuvastatin and ezetimibe in pharmaceutical formulations.

Keywords

• RP-HPLC
• Rosuvastatin
• Ezetimibe
• Isocratic
• ICH guidelines