Development and Validation of A Green HPLC Method for Estimation of Empagliflozin in Pharmaceutical Products

Authors : İbrahim Bulduk, Erten Akbel, Serdar Güngör, Süleyman Gökce

Pages : 1333-1352

Doi:10.47495/okufbed.1626492

View : 22 | Download : 20

Publication Date : 2025-06-16

Article Type : Research Paper

Abstract :In this study, two different chromatographic methods were developed for the quantification of empagliflozin in pharmaceutical products. The first was the classical method using acetonitrile as an organic modifier in the mobile phase and the second was the green method using ethanol as an organic modifier in the mobile phase. In the classical method, an Extend C18 column (250 x 4.6 mm, 5 µm) was used and the temperature was kept constant at 30 °C. The mobile phase was the formic acid solution (0.1% in ultrapure water) and acetonitrile (55/45, v/v), and isocratic elution was applied. The flow rate of the mobile phase was 1.0 mL min-1 and the injection volume was 10 µL. Detection was performed using a UV detector at 223 nm. In the green method, ethanol was used as an organic modifier. The only difference between these methods was the organic modifier. All other conditions of the methods were identical. Both chromatographic methods were validated according to ICH guidelines for various parameters such as selectivity, linearity, accuracy, precision, limit of detection and quantification, and robustness. The coefficients of determination of the chromatographic methods were greater than 0.999 in the concentration range of 5-30 mg mL-1 glyclazide. The developed chromatographic methods were applied to pharmaceutical formulations. Comparisons of the results obtained in terms of means were made using the Student (t) test and in terms of standard deviations using the Fischer (F) test. There was no significant difference between these methods. The environmental impact of both methods was evaluated using AGREE and GAPI software, confirming their sustainability. These validated methods provide reliable and environmentally friendly approaches for the quantitative analysis of EPG in tablet formulations, supporting safer and more sustainable laboratory practices in pharmaceutical analysis. For the quantitative analysis of EPG in pharmaceutical products, the new approach can be viewed as an affordable and ecologically responsible alternative to the methods now in use.
Keywords : Yeşil analitik metod, empagliflozin, kromatografik metod

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