To Develop and Validate the Stability Indicating Method for Ezetimibe and Rosuvastatin Using HPLC Method

Abstract

A reverse-phase HPLC (RP-HPLC) method has been developed and validated which is simple, fast, accurate of Rosuvastatin and Ezetimibe in the pharmaceutical tablet dose. The separation was done on C18 column (250 × 4.6 mm, 5 µm) with Methanol acid (60:40, v/v) as mobile phase flow rate of 1.0 mL/min at the isosbestic wavelength of 233 nm detected using UV detectors. With the optimized method, well-resolved peaks were obtained for Rosuvastatin around 3.39 min and Ezetimibe around 4.58 min. The method was validated according to the guidelines outlined by ICH Q2(R2) and was found to be linearly in the range of 6-30 µg/mL for Rosuvastatin and 3-15 µg/mL for Ezetimibe with correlation coefficient near unity. The accuracy was found between 98.96 to 100.29% for Rosuvastatin and 98.46–100.74% for Ezetimibe and repeatability, intraday precision and interday precision showed %RSD values less than 2% proving the precision of the method. The developed method was determined to be specific, sensitive, rugged and robust with good limits of detection and limits of quantitation and validated successfully for the determination of marketed tablet formulations, giving a high accuracy of 99.81% for Rosuvastatin, 99.68% of Ezetimibe. Forced degradation studies conducted in acidic, alkaline, oxidative and photolytic conditions proved that the method was suitable for identifying degradation products from Rosuvastatin and Ezetimibe, the latter being relatively more susceptible to degradation than Rosuvastatin. The developed method of RP-HPLC is simple, economical, reliable, routine QC method and can be used for stability study of model compound and simultaneous estimation of Rosuvastatin and Ezetimibe in combined pharmaceutical dosage formulation.