ArticleInternational journal of molecular sciences2025
Optimized and Validated Stability-Indicating RP-HPLC Method for Comprehensive Profiling of Process-Related Impurities and Stress-Induced Degradation Products in Rivaroxaban (XARELTO)
Article in International journal of molecular sciences, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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6 citing papers in PubMed.
- Validated stability indicating reverse phase liquid chromatography method for oxcarbazepine and its degradation products with greenness evaluation.Scientific reports · 2026Article
- Effects of Botanical Variation, Plant Part, and Extraction Technique on Mitragynine and 7-Hydroxymitragynine in Kratom (Molecules (Basel, Switzerland) · 2026Article
- Structural Characterization, Toxicity Assessment and Molecular Modeling of Forced Degradation Products of Siponimod.International journal of molecular sciences · 2026Article
- A stability-indicating RP-HPLC method for the simultaneous quantification of brimonidine tartrate and timolol maleate in bulk drug substances and pharmaceutical dosage forms.Scientific reports · 2026Article
- Exploring Carboxamide Derivatives as Promising Anticancer Agents: Design, In Vitro Evaluation, and Mechanistic Insights.International journal of molecular sciences · 2025Article
- A novel reversed phase high performance liquid chromatography approach for stability-indicating simultaneous analysis of brimonidine tartrate and timolol maleate.Frontiers in chemistry · 2025Article
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Abstract
An isocratic reverse-phase high-performance liquid chromatography (RP-HPLC) method, coupled with photodiode array detection (PDA), was developed for the identification and characterization of stress degradation products and an unknown process-related impurity of rivaroxaban in bulk drug form. Rivaroxaban, a selective and direct Factor Xa inhibitor, underwent forced degradation under hydrolytic (acidic, alkaline, and neutral), photolytic, thermal, and oxidative stress conditions, following the ICH's guidelines. The drug displayed significant susceptibility to acid, base, and oxidative environments leading to the formation of eleven degradation products. All degradation products, along with process impurities and Rivaroxaban, were effectively separated using a (4.6 × 250 mm, 5 µm) C18 Thermo ODS Hypersil column at ambient temperature. The mobile phase composed of acetonitrile and monobasic potassium phosphate (pH 2.9) in a 30:70 (
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