Stability-indicating method for the determination of Rivaroxaban and its degradation products using LC-MS and TLC

Arous, Basima, Al-Mardini, Mohammad Amer, Ghazal, Heba and Al-Lahham, Fida (2018) Stability-indicating method for the determination of Rivaroxaban and its degradation products using LC-MS and TLC. Research Journal of Pharmacy and Technology, 11(1), pp. 212-220. ISSN (print) 0974-3618

Abstract

A validated stability indicating thin layer chromatographic (TLC) and liquid chromatography coupled with mass spectrometry LC/MS methods were developed to analyse Rivaroxaban and its degradation products. Forced degradation studies under stress conditions were carried out in order to establish its stability profile. Stress conditions recommended by the International Conference on Harmonization (ICH) including oxidative, photolytic, thermal, acidic, and basic hydrolysis were applied. Rivaroxaban found susceptible to acid and base hydrolytic stress conditions. Degradation products were identified isolated and characterized using LC-MS and TLC. Three major degradation products were detected, separated and determined and two of them were further characterized by NMR spectroscopy and FT-IR.

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