Stability-indicating method for the determination of Rivaroxaban and its degradation products using LC-MS and TLC
| Autor: | Heba Ghazal, Basima Arous, Mohammad Amer Al-Mardini, Fida Al-Lahham |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
pharmacy
Chromatography Chemistry 010401 analytical chemistry 02 engineering and technology Nuclear magnetic resonance spectroscopy 021001 nanoscience & nanotechnology Mass spectrometry 01 natural sciences 0104 chemical sciences Hydrolysis Liquid chromatography–mass spectrometry Stability indicating Forced degradation Degradation (geology) Pharmacology (medical) Stress conditions 0210 nano-technology Pharmacology Toxicology and Pharmaceutics (miscellaneous) |
| ISSN: | 0974-3618 |
| Popis: | A validated stability indicating thin layer chromatographic (TLC) and liquid chromatography coupled with mass spectrometry LC/MS methods were developed to analyze 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. |
| Databáze: | OpenAIRE |
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