Simultaneous estimation of Atorvastatin and Ezetimibe in pharmaceutical formulations by RP-HPLC method

By Jayapal Reddy Sama, Rama Rao Kalakuntla, V. Surya Narayana Rao, P. Reddanna

Objective

Atorvastatin and Ezetimibe are used to treat hyperlipidemia. A simple, precise cost effective and stability indicating RP-HPLC method has been developed and validated for the simultaneous determination of Atorvastatin and Ezetimibe in pharmaceutical formulations. Separation of both Atorvastatin and Ezetimibe was achieved with in 5 minutes with required resolution, accuracy and precision thus enabling the utility of the method for routine analysis. Chromatographic separation was achieved on a Waters Symmetry C18 3.5µm, 150 mm x 3.0 mm using a mobile phase consisting of 0.05M phosphate buffer pH3.0 and Acetonitrile in the ratio of 45:55 at a flow rate of 0.8ml per minute. The detection was made at 236nm. The retention time of Atorvastatin and Ezetimibe were2.5 and 2.0 minutes respectively. The method was found linear over the range of 5-15 µg per ml for Ezetimibe and 40-120 µg per ml for Atorvastatin. The proposed method was validated as per the ICH and USP guidelines.

 

Key Words :Atorvastatin, Ezetimibe, HPLC and validation

 

Click here to download the complete article in PDF Format