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@article{203547,
        author = {Mr. Nishant P. Kolte and Dr. Ananta U. Gite and Nandu Kayande},
        title = {TO ESTABLISH AND VERIFY A STABILITY INDICATING TECHNIQUE FOR RP-HPLC-BASED RIVAROXABAN ESTIMATION FROM BULK AND TABLET DOSAGE FORMS},
        journal = {International Journal of Innovative Research in Technology},
        year = {2026},
        volume = {12},
        number = {12},
        pages = {10680-10688},
        issn = {2349-6002},
        url = {https://ijirt.org/article?manuscript=203547},
        abstract = {An oral anticoagulant called rivaroxaban is frequently used to prevent and treat thromboembolic conditions such atrial fibrillation-related stroke, pulmonary embolism, and deep vein thrombosis. Rivaroxaban's growing clinical use has made accurate and dependable analytical techniques for its quantification in pharmaceutical dosage forms and bulk pharmacological substances necessary. Because of its sensitivity, accuracy, specificity, and repeatability, Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) has become one of the most successful analytical techniques.
The stability-indicating RP-HPLC techniques developed for the assessment of rivaroxaban in pharmaceutical dosage forms and bulk drug substances are compiled in this review. There includes a thorough discussion of various chromatographic circumstances, including flow rate, detection wavelength, retention behavior, mobile phase optimization, and stationary phase selection. To provide adequate peak resolution and save analysis time, the majority of analytical techniques use traditional C18 columns with mobile phases made of acetonitrile or methanol mixed with acidic aqueous buffers.
In order to assess the stability-indicating potential of the new techniques, the review additionally concentrates on forced degradation investigations carried out under acidic, alkaline, oxidative, thermal, and photolytic stress conditions. According to published research, rivaroxaban significantly degrades in oxidative and alkaline environments, however breakdown products can be successfully separated from the active ingredient using specialized RP-HPLC techniques.
Furthermore, the review highlights method validation parameters performed according to International Council for Harmonization guidelines, including specificity, linearity, precision, accuracy, robustness, sensitivity, limit of detection, and limit of quantification. The reported analytical methods demonstrate excellent reproducibility, accuracy, and suitability for routine pharmaceutical quality control analysis and stability testing. Overall, stability-indicating RP-HPLC methods are considered reliable, economical, and efficient analytical tools for the estimation and stability evaluation of Rivaroxaban in pharmaceutical industries and research laboratories.},
        keywords = {Rivaroxaban, RP-HPLC, stability indicating method, method validation, bulk drug analysis, tablet dosage form, pharmaceutical analysis, forced degradation studies, ICH guidelines, analytical method development.},
        month = {May},
        }