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Arous, Basima
- Stability-Indicating Method for the Determination of Rivaroxaban and its Degradation Products using LC-MS and TLC
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Authors
Affiliations
1 Department of Pharmaceutical, Chemistry and Quality Control, Damascus University, Damascus, Syria, SY
2 Department of Pharmacy, Kingston University, Penrhyn Road, Kingston Upon Thames, Surrey KT1 2EE, GB
3 Department of Chemistry, Damascus University, Damascus, Syria., SY
1 Department of Pharmaceutical, Chemistry and Quality Control, Damascus University, Damascus, Syria, SY
2 Department of Pharmacy, Kingston University, Penrhyn Road, Kingston Upon Thames, Surrey KT1 2EE, GB
3 Department of Chemistry, Damascus University, Damascus, Syria., SY
Source
Research Journal of Pharmacy and Technology, Vol 11, No 1 (2018), Pagination: 212-220Abstract
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.Keywords
Rivaroxaban, LC-MS, TLC, Stability Indicating, Degradation Products.
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