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Stability-Indicating Method for the Determination of Rivaroxaban and its Degradation Products using LC-MS and TLC


Affiliations
1 Department of Pharmaceutical, Chemistry and Quality Control, Damascus University, Damascus, Syria, Syrian Arab Republic
2 Department of Pharmacy, Kingston University, Penrhyn Road, Kingston Upon Thames, Surrey KT1 2EE, United Kingdom
3 Department of Chemistry, Damascus University, Damascus, Syria., Syrian Arab Republic
     

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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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  • Stability-Indicating Method for the Determination of Rivaroxaban and its Degradation Products using LC-MS and TLC

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Authors

Basima Arous
Department of Pharmaceutical, Chemistry and Quality Control, Damascus University, Damascus, Syria, Syrian Arab Republic
Mohammad Amer Al-Mardini
Department of Pharmaceutical, Chemistry and Quality Control, Damascus University, Damascus, Syria, Syrian Arab Republic
Heba Ghazal
Department of Pharmacy, Kingston University, Penrhyn Road, Kingston Upon Thames, Surrey KT1 2EE, United Kingdom
Fida Al-Lahham
Department of Chemistry, Damascus University, Damascus, Syria., Syrian Arab Republic

Abstract


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.

References