Abstract
A facile method is proposed herein for simultaneous quantification of ezetemibe, atorvastatin and simvastatin in their commercial tablets. In this study FTIR procedure is described for the simultaneous quantitative determination of two commercial tablet dosage forms composed of (ezetemibe – atorvastatin) and (ezetemibe – simvastatin). For the developed FTIR spectroscopic method, potassium bromide (KBr) disc technique had been used. Specific absorption bands at 514, 1651 and 868 cm−1 were chosen for selective simultaneous analysis of ezetemibe, atorvastatin and simvastatin respectively. In this method, beer’s law was obeyed in the concentration ranges 0.06 –0.40 and 0.12 – 0.30 % w/w in KBr disc for the investigated drugs alone and at their synthetic binary mixtures respectively. Validation study was performed using USP XXV validation and International Conference on Harmonization (ICH) guidelines and resulted in good recoveries ranged from 87.24 to 104.24 % with relative standard deviations less than 8.00 % depicting accuracy, precision, robustness and ruggedness of the developed method. Excellent recoveries were obtained upon application of the developed method to their commercial binary tablets ranged from 92.00 to 100.54 % conforming the suitability of the proposed method for routine analysis at the quality control laboratories.