Mean centering method for determination of empagliflozin and metformin

Authors

Bassam M. Ayoub, The British University in EgyptFollow
Rola M. Emam, The British University in Egypt
Mahmoud M. Youssef, The British University in Egypt
Muhammad N. El-Kattan, The British University in Egypt
Marwa A. Sayed, The British University in Egypt
Ahmed M. Kowider, The British University in Egypt
Adly H. Seha, The British University in Egypt
Engy A. Rabea, The British University in Egypt
Rana M. Yakout, The British University in Egypt
Rolly H. Faried, The British University in Egypt

Document Type

Article

Publication Date

1-1-2017

Abstract

© 2017, Marmara University. All rights reserved. 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 μg/mL 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.

Recommended Citation

Ayoub, B.M., Emam, R.M., Youssef, M.M., El-Kattan, M.N., Sayed, M.A., Kowider, A.M., Seha, A.H., Rabea, E.A., Yakout, R.M., Faried, R.H. Mean centering method for determination of empagliflozin and metformin (2017) Marmara Pharmaceutical Journal, 21 (3), pp. 669-674.