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Development and Validation of a Liquid Chromatography Method for the Analysis of Rivaroxaban and Determination of Its Production Related Impurities

Pharmaceutical Chemistry Journal volume 52, pages 483–490 (2018)Cite this article

The purpose of this work was to develop a sensitive and validated HPLC method for analysis of rivaroxaban and estimation of related impurities in parent drug substance and pharmaceutical dosage forms. The analysis was carried out on a Macherey-Nagel Nucleodur C18 column (250 × 4.6 mm, 5 μm particle size) with a mobile phase containing acetonitrile and water in gradient program at a flow rate of 1.5 mL/min, the column oven temperature 55°C, and the UV detector wavelength set at 254 nm. The method was validated according to USP38-NF33 guideline recommendations and to the ICH guidelines for validation. The linearity, selectivity, accuracy, precision, robustness, LOD and LOQ characteristics of the proposed method showed acceptable values. The method is suitable for practical routine analysis of drug substance and pharmaceutical dosage forms, and it was successfully used to analyze Rovaltro (Syrian product) and Xarelto (brand product). All the analysis results were acceptable according to pharmaceutical requirements.

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Acknowledgments

The authors are thankful to colleagues in the central laboratory of the Faculty of Science for their cooperation in carrying out this work. The authors would like to thank Dr. Heba Ghazal for her help in funding the project.

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Authors and Affiliations

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

    Basima Arous & Mohammad Amer Al-Mardini

  2. Department of Chemistry, Faculty of Sciences, Damascus University, Damascus, Syria

    Francois Karabet, Manal Daghestani, Fida Al-Lahham & Alyamama Al-Askar

Authors
  1. Basima Arous
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  2. Mohammad Amer Al-Mardini
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  3. Francois Karabet
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  4. Manal Daghestani
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  5. Fida Al-Lahham
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  6. Alyamama Al-Askar
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Correspondence to Basima Arous.

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Arous, B., Al-Mardini, M.A., Karabet, F. et al. Development and Validation of a Liquid Chromatography Method for the Analysis of Rivaroxaban and Determination of Its Production Related Impurities. Pharm Chem J 52, 483–490 (2018). https://doi.org/10.1007/s11094-018-1844-z

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  • DOI: https://doi.org/10.1007/s11094-018-1844-z

Keywords

  • rivaroxaban
  • product related impurities
  • HPLC
  • validation