Mean Centering Method for determination of Empagliflozin and Metformin

Year 2017, Volume: 21 Issue: 3, 669 - 674, 24.06.2017

Bassam M Ayoub Rola M Emam Mahmoud M Youssef Muhammad N El-kattan Marwa A Sayed Ahmed M Kowider Adly H Seha Engy A Rabea Rana M Yakout Rolly H Faried

https://doi.org/10.12991/marupj.323590

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 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.

Keywords

Spiking; Chemometry; Computer-assisted analysis; Mean Centering; Empagliflozin; Metformin

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