Structural identification and estimation of Rosuvastatin calcium related impurities in Rosuvastatin calcium tablet dosage form

Abstract

A precise, accurate, specific, linear, rugged and robust analytical method was developed and validated for estimation of process and degradant impurities of Rosuvastatin calcium (RSC) in Rosuvastatin calcium tablets. 150 mm length column, 4.6 mm diameter and 3.5μ particle size with C18 stationary phase and pH3.0 phosphate buffer as mobile phase. Column was maintained at 30 °C.All impurities are monitored at 248 nm.Impurities are separated in gradient elution mode. All degradant impurities of RSC (Anti-isomer, 5-ketoacid, lactone and meglumine adduct), process impurity (Imp-A) are well separated. Unknown impurity (Meglumine adduct) formed during stability studies was isolated using preparative HPLC and structure was characterized by NMR and Mass spectrometry (LC-MS and HRMS) studies. Method is capable of separating and estimating all the degradant and process impurities.