Mean Centering Method for determination of Empagliflozin and Metformin

Abstract

Introduction of computer-assisted analysis to pharmaceutical products is considered a significant approach. A new method was developed for simultaneous determination of empagliflozin and metformin manipulating their ratio spectra with application on recently approved pharmaceutical combination, Synjardy ® tablets. Spiking technique was used to increase the concentration of empagliflozin after extraction from tablets to allow its simultaneous determination with metformin without prior separation. Validation parameters according to ICH guidelines were acceptable over the concentration range of 2-12 μgml -1 for both drugs. Mean centering was performed using Minitab ® program. Using computer assisted programs after spiking accompanied with direct UV measurement of the drugs was satisfactory for accurate assay without complex instrumentations. The optimized method was proved to be suitable for industrial QC labs.