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Research Journal of Pharmacy and Technology
Year : 2018, Volume : 11, Issue : 1
First page : ( 212) Last page : ( 220)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2018.00040.9

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

Arous Basima1,*, Al-Mardini Mohammad Amer1, Ghazal Heba2, Al-Lahham Fida3

1Department of Pharmaceutical, Chemistry and Quality Control, Faculty of Pharmacy, Damascus University, Damascus, Syria

2Department of Pharmacy, Kingston University, Penrhyn Road, Kingston Upon Thames, Surrey KT1 2EE, UK

3Department of Chemistry, Faculty of Sciences, Damascus University, Damascus, Syria

*Corresponding Author E-mail: basima.arous@gmail.com

Online published on 12 June, 2018.

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.

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Keywords

Rivaroxaban, LC-MS, TLC, stability indicating, degradation products.

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