Novel and stability indicating HPLC method for Ezetimibe, Rosuvastatin, Atorvastatin in tablets form

DOI: https://doi.org/10.55434/CBI.2020.8101

Abstract

Rugged and robust HPLC method was developed for assay determination of Ezetimibe, Rosuvastatin, and Atorvastatin in tablet dosage form. These three drugs used to treat the human body bad and good cholesterol management in blood. Ezetimibe and rosuvastatin are available in the market in tablets dosage form; Ezetimibe and atorvastatin combinations also available in the market. 0.05 M KH2PO4 buffer was used as mobile phase A and acetonitrile is used as mobile phase B. Gradient program was used as eluent, 30% of mobile phase B at 0 min; 30 % at 5 min; 42% at 8 min; 40 % at 12 min; and 30 % at 16 min and 30 % at 20 min. Agilent make Zorbax SB C18 150*4.6 mm, 5 µ HPLC column was used. 20 µL injection volume, 20 min runtime, 1.0 ml/min flow rate, 230 nm and 50°C column oven temperature were applied for analysis. Mobile phase A and B were mixed in the ratio of 50:50 v/v and used as diluent. All three analytes were eluted with high resolution and the retention time of ezetimibe 15.3 min, rosuvastatin 9.0 min and atorvastatin 17.1 min. method validation was performed as per ICH quality guidance. Results were achieved with accuracy and precision. Hence, the developed and validated method was applicable for routine drug product manufacturing quality evaluation.