UHPLC Specific Method for Simultaneous Determination of Probable Impurities of Ezetimibeand Simvastatin in Combined Dosage Form

Abstract

Method development, degradation impurities that may appear in Ezetimibe, Simvastatin tablets with Ultra High Performance Liquid Chromatography (UHPLC or UPLC) technique. Water’s Acquity High strength (HSS) T31.8µ, 100x 2.1mm column is used for critical separation between closely eluting impurities originating from the combined dosage form. Perchloric acid buffer (1.0 mL/L)and acetonitrile are selected as Elution phase A, B. The resolution between polar, mid polar and highly polar impurities is achieved with flow of 0.5 mL per minute in step gradient mode with short run time. Detection was done at 238nm for quantification of both Ezetimibe and Simvastatin impurities. Method validation is performed as per compound requirement. The validated UHPLC method is specific and stability demonstrating for process or degradation impurities that may originate from drug product or peaks appears during stress degradation in Ezetimibe and Simvastatin tablets . The method was accurate, robust and validation is as per ICH guide lines. The results are more reliable, precise and reproducible.