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.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
