Open Access Peer-reviewed Research Article

Development and validation of a stability-indicating HPLC assay method for determination of ethacrynic acid in solution formulation. HPLC-MS identification of hydrolytic and oxidative degradation products

Main Article Content

Mónika Kuzma corresponding author
Veronika Murányi
Mátyás Mayer
Zsuzsanna Rozmer
Pál Perjési

Abstract

An isocratic stability-indicating HPLC assay method was developed to quantitate ethacrynic acid in solution formulations. Utilizing the method, the main hydrolytic, and one of the oxidative degradation products could be separated. The structure of the separated degradation products was confirmed by negative ion-mode HPLC-MS. The hydrolytic results confirmed the previously reported sequence of the formation of the dimeric Michael adduct. One new oxidative metabolite has been identified. The validated analytical method can be used to quantitate ethacrynic acid in a solution formulation in the 0.5-500 µg/ml concentration range.

Keywords
forced degradation, hydrolytic degradation products, oxidative degradation products, michael addition reaction, stability-indicating HPLC method, HPLC-MS

Article Details

Supporting Agencies
This work was supported by the National Office of Research and Technology, “Pázmány Péter program” (RET-II 08/2005), the European Union, co-financed by the European Social Fund (EFOP-3.6.1.-16-2016-00004).
How to Cite
Kuzma, M., Murányi, V., Mayer, M., Rozmer, Z., & Perjési, P. (2020). Development and validation of a stability-indicating HPLC assay method for determination of ethacrynic acid in solution formulation. HPLC-MS identification of hydrolytic and oxidative degradation products. Journal of Pharmaceutical and Biopharmaceutical Research, 2(1), 131-144. https://doi.org/10.25082/JPBR.2020.01.005

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