A Bioequivalence study comparing fixed dose combination of Atorvastatin 10 mg and Metformin 500 mg ER tablet with single doses of Lipitor® 10 mg and Glucophage® 500 mg XR tablets administered concurrently in healthy human subjects

Abstract

In this study single oral dose bioequivalence of the test formulation i.e. fixed dose combination tablet of Atorvastatin 10 mg (as Atorvastatin calcium) and Metformin HCl 500 mg ER of Ranbaxy Laboratories Limited, with Lipitor® tablets (containing Atorvastatin 10 mg as Atorvastatin calcium) of Pfizer and Glucophage® XR tablets (containing Metformin HCl 500 mg) of Bristol-Myers Squibb company were evaluated.The clinical study was carried out in accordance with ICH Good Clinical Practices.A high performance liquid chromatographic tandem mass spectrometric method for the estimation of Atorvastatin, o-Hydroxy Atorvastatin and p-Hydroxy Atorvastatin in human plasma was developed and validated using Atorvastatin D5, o-Hydroxy Atorvastatin D5 and p-Hydroxy Atorvastatin D5 as internal standards respectively and a high performance liquid chromatographic tandem mass spectrometric method for the estimation of Metformin in human plasma was developed and validated using ranitidine as internal standard. The method was linear between 0.103-200.867 ng/ml for Atorvastatin and 20.6-3219.5 ng/ml for Metformin.As a result of analysis and study the test product is bioequivalent with the reference product.