Abstract

DEVELOPMENT OF IN-VITRO DISSOLUTION METHOD FOR FIXED-DOSE COMBINATION OF ATORVASTATIN AND EZETIMIBE

Navjot K Sandhu, Pawan K Porwal, Pooja A. Chawla*, Anshul Chawla, Rajiv Sharma

ABSTRACT

This investigation aimed to develop and validate a dissolution method for a combination of atorvastatin and ezetimibe tablets using the spectroscopic and liquid chromatographic method. The analytical method was developed by UV spectrophotometry using the absorbance ratio method which involves the measurement of absorbance at two wavelengths 246 nm as the λmax of atorvastatin and 233nm for ezetimibe. The method was carried out using Waters X-Bridge C18 250 x 4.6 mm i.D., 5 m. The mobile phase consists of Acetonitrile: Water: Methanol having a ratio of 60:30:10v/v/v. The pH of the mobile phase was adjusted up to 3 with orthophosphoric acid. The flow rate was 1.0mL/min and detection carried out at 233 nm. The method was validated according to ICH guidelines which include accuracy, precision, specificity, linearity, and analytical range. Based on this, the established dissolution conditions were 900 mL of 0.1 N HCl as dissolution medium at 37±0.5 °C, using USP apparatus II at a stirring rate of 75 rpm at different time points ranges from 5,10,15,30,45and 60min. The corresponding dissolution profiles were constructed for the selected brand showed more than 80% drug release within 45 minutes. Different concentrations of SLS were also used to observe the effect and to reduce any variations. The method was validated according to ICH guidelines which include accuracy, precision, specificity, linearity, and analytical range. Thus, the proposed dissolution method and analytical method can be applied successfully for the Quality control of atorvastatin and ezetimibe in marketed tablets.

Keywords: Dissolution, Atorvastatin, ICH Guidelines, Ezetimibe, UV Spectrophotometric Method.