Ezetimibe

A simple, Accurate, precise method was developed for the simultaneous estimation of the Bempedoic acid and Ezetimibe in bulk and tablet dosage form.(1) Chromatogram was run through Kromosil C18 150 x 4.6 mm, 3.0m. Mobile phase containing 0.01N Kh2Po4 Buffer: Methanol taken in the ratio 70:30 was pumped through the column at a flow rate of 0.9ml/min. The buffer used in this method was 0.01N Kh2Po4 buffer. Temperature was maintained at 30°C. The optimized wavelength selected was 260.0 nm. The retention time of Bempedoic acid and Ezetimibe was found to be 2.780min and 2.123min. %RSD of the Bempedoic acid and Ezetimibe were found to be 0.6 and 1.3 respectively. % Recovery was obtained as 99.87% and 100.12% for Bempedoic acid and Ezetimibe respectively. LOQ, and LOD values obtained from regression equations of Bempedoic acid and Ezetimibe were 0.10, 0.35, and 0.01, 0.03 respectively. The regression equation of Bempedoic acid is y = 28262x + 4418.6, and y = 28796x + 190.13 of Ezetimibe. Retention times were decreased and that run time was decreased, so the method developed was simple and economical and can be adopted in regular Quality control tests in Industries.       

A new simple, accurate, rapid and precise isocratic RP-HPLC was developed and validated for the determination of Rosuvastatin and Ezetimibe in Pharmaceutical tablet dosage form by droping method. The Method employs Shimadzu LC system on Hypersil ODS column (4.6 x 250 mm, 5 µm) and flow rate of 1.5ml/min with an injection volume 20µl.  Buffer, Acetonitrile and Methanol was used as mobile phase in the composition of 40:30:30v/v. The Detection was carried out at 230nm. Linearity ranges for Rosuvastatin and Ezetimibe were 11-33µg/ml, 10-30µg/ml respectively for HPLC. Retention Time of Rosuvastatin and Ezetimibe were found to be 3.7 and 5.7 min respectively. Percent Recovery study values of Rosuvastatin and Ezetimibe were found 99.6-101.1% and 99.9-100.7% respectively. This newly developed method i.e. droping method was successfully utilized for the Quantitative estimation of Rosuvastatin and Ezetimibe in tablet dosage form. This method was validated for selectivity, accuracy, precision, and linearity, Ruggedness, Robustness and Stability Studies as per ICH guidelines.