Abstract

A REVIEW ON DEVELOPMENT AND VALIDATION OF METHOD FOR DETERMINATION OF SOME RECENT MARKETED FORMULATION CONTAINING ROSUVASTATIN AND EZETIMIBE

Mamta Devidas Dhande*, Dr. Sachin C. Kale, Dr. Kailash R. Biyani

Abstract

Rosuvastatin (RST) is chemically designated as (3R, 5S, 6E) - 7 - [4 - (4 - fluorophenyl) - 2 - (N - methylmethanesulfonamido) - 6 - (propan - 2 - yl) pyrimidin - 5 - yl] - 3, 5 - dihydroxyhept - 6 - enoic acid. It is a member of the drug class of statins. It reduces levels of low-density lipoprotein, apolipoprotein B and triglycerides in the blood, while increasing levels of high-density lipoprotein in the management of hyper lipidaemias. Ezetimibe (EZT) chemically designated as (3R, 4S) - 1 - (4 - fluorophenyl) - 3 - [(3S) - 3 - (4 - fluorophenyl) - 3 - hydroxypropyl] - 4 - (4 - hydroxyphenyl) azetidin - 2 – one. It is a selective cholesterol absorption inhibitor, used for the treatment of hyperlipidemia, which potentially inhibits the absorption of biliary and dietary cholesterol. Future validations will focus on demonstrating method reliability across various laboratories, ensuring resilience to minor fluctuations in testing conditions, thus enhancing reproducibility and compliance with International Conference on Harmonisation (ICH) guidelines. The integration of automation in sample preparation and analysis is expected to improve operational efficiency, with Process Analytical Technology (PAT) allowing for real-time monitoring during manufacturing processes. This approach will yield high-quality data and necessitate sophisticated validation protocols to maintain regulatory compliance. An analytical method using reversed-phase high-performance liquid chromatography (RP-HPLC) was developed and validated for the simultaneous determination of rosuvastatin and ezetimibe in commercial tablet formulations. This method, validated according to ICH guidelines, is described as simple, sensitive, accurate, precise, linear, robust, and specific, making it suitable for routine quality control and stability studies.

Keywords: RP-HPLC, Rosuvastatin, Ezetimibe, Isocratic, ICH guidelines.