Editor-in-Chief
Hatice Kübra Elçioğlu
Vice Editors
Levent Kabasakal
Esra Tatar
Online ISSN
2630-6344
Publisher
Marmara University
Frequency
Bimonthly (Six issues / year)
Abbreviation
J.Res.Pharm.
Former Name
Marmara Pharmaceutical Journal
Marmara Pharmaceutical Journal
2017 , Vol 21 , Issue 3
Mean Centering Method for determination of Empagliflozin and Metformin
1Chemistry Department, Faculty of Pharmacy, The British University in Egypt, Cairo 11837, Egypt
DOI :
10.12991/marupj.323590
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