Key result
New RP-HPLC method accurately identifies rivaroxaban impurities and stress degradation products with ~99% recovery.
Population
Rivaroxaban in bulk drug form
Design
In vitro analytical method development and validation study
Authors
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May aid rivaroxaban quality control; leaves open broader clinical validation and adoption.
A validated RP-HPLC method was developed for the reliable analysis and quality control of rivaroxaban and its degradation products.
Aktham Mestareehi (2025) studied this question. Rivaroxaban was evaluated on Method validation (specificity, linearity, accuracy, precision, robustness). An isocratic RP-HPLC method was successfully developed and validated for identifying stress degradation products and process-related impurities of rivaroxaban, with recovery rates of 98.6–103.4%.
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