Open Access Subscription Access
Open Access Subscription Access
Stability-Indicating Method for the Determination of Rivaroxaban and its Degradation Products using LC-MS and TLC
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.
Rivaroxaban, LC-MS, TLC, Stability Indicating, Degradation Products.
- "Xarelto: Summary of Product Characteristics". Bayer Schering Pharma AG. 2008.
- AG BP. Xarelto® (rivaroxaban) summary of product characteristics. 2013. 2012.
- Bayer Pharma A. Xarelto® summary of product characteristics. 2015. 2015.
- Williams A. ChemSpider and Its Expanding Web. Chemistry International. 2008; 30(1):30.
- Guideline IHT. Stability testing of new drug substances and products. Q1A (R2), current step. 2003;4.
- Guideline IHT. Photostability testing of new drug substance and products. Fed Register. 1996; 62:27115-22.
- Rao P, Cholleti V, Reddy V. Stability-indicating UPLC method for determining related substances and degradants in Rivaroxaban. International Journal of Research in Pharmacy and Science. 2015; 5(2):17 – 24.
- Rajan N, Basha KA. A Stability-Indicating Ultra-Performance Liquid Chromatographic Method for Estimation of Related Substances and Degradants in Rivaroxaban Active Pharmaceutical Ingredient. Journal of Pharmacy Research Vol. 2014; 8(11):1719-25.
- Mostafa Aa LIB. High Performance Liquid Chromatography, TLC Densitometry, Firstderivative and First-derivative ratio Spectrophotometry for de-termination of Rivaroxaban and its alkaline Degradates in Bulk Powder and its Tablets. Journal of Chromatography and Separation Techniques. 2013; 04(09).
- Pinaz AK, Muralikrishna K. Method development and acid degradation study of rivaroxaban by RP-HPLC in bulk. Asian Journal of Pharmaceutical Analysis. 2013;3(2):62-5.
- Kasad PA, Muralikrishna K. Base degradation study and method development of rivaroxaban by RP-HPLC in bulk. Asian Journal of Pharmacy and Technology. 2013;3(3):98-101.
- Kasad PA. Photolytic-thermal degradation study and method development of rivaroxaban by RP-HPLC. International Journal of PharmTech Research. 2013; 5(3):1-5.
- Ramisetti NR, Kuntamukkala R. Development and validation of a stability indicating LC-PDA-MS/MS method for separation, identification and characterization of process related and stress degradation products of rivaroxaban. RSC Advances. 2014; 4(44):23155.
- Abdallah MA, Al-Ghobashy MA, Lotfy HM. Investigation of the profile and kinetics of degradation of rivaroxaban using HPLC, TLC-densitometry and LC/MS/MS: Application to pre-formulation studies. Bulletin of Faculty of Pharmacy, Cairo University. 2015; 53(1):53-61.
- Wingert NR, dos Santos NO, Nunes MA, Gomes P, Müller EI, Flores ÉM, et al. Characterization of three main degradation products from novel oral anticoagulant rivaroxaban under stress conditions by UPLC-Q-TOF-MS/MS. Journal of pharmaceutical and biomedical analysis. 2016; 123:10-5.
- European Pharmacopoeia -7th- Edition 2010.
- Pharmacopoeia B. Volume V, XVII G, H and XII B1. London: British Pharmacopoeia Commission. 2017.
- USP. United States Pharmacopeia-National Formulary, USP 35-NF 30. Rand McNally, Rockville, USA; 2013.
- Guideline IHT. Validation of analytical procedures: text and methodology. Q2 (R1). 2005; 1.
Abstract Views: 16
PDF Views: 0