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Forced Degradation Studies of Sofosbuvir with a Developed and Validated RP-HPLC Method as per ICH Guidelines

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Abstract

A reverse phase-high-performance liquid chromatography-diode array detector method is developed for the determination of the antiviral drug sofosbuvir in bulk and Sofos® 400 mg tablet dosage forms. Sofosbuvir is used for the treatment of chronic hepatitis C. The separation is carried out using a gradient mobile phase consisting of 0.05% H3PO4 and acetonitrile. A symmetry C18 column (4.6 × 100 mm, 2.5 µm, Waters XSELECT HSS T3) is used with a flow rate of 1.5 mL min−1 using ultraviolet detection at 260 nm with a diode array detector and an injection loop volume of 10 µL. A sharp peak is obtained at a retention time of 14 min. The method is validated appropriately according to the requirements of the United States Pharmacopeia and the International Conference on Harmonization guideline Q2 R1. System suitability, linearity, range (1.5–4.5 µg mL−1), precision, accuracy, specificity, robustness, detection and quantification limit of the method are assured. A forced degradation study of sofosbuvir is conducted under the conditions of hydrolysis, oxidation, thermal and photolysis.

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Acknowledgements

The corresponding authors wish to convey his sincere thanks to BEKER Laboratories LDA team for their valuable help, support, inspiration and for providing generic products and reference standards.

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Authors and Affiliations

  1. Faculty of Process Engineering, University of Constantine, 3, Ali Mendjeli, 25000, Constantine, Algeria

    Abderrazaq Hamdache

  2. Laboratory of Process and Environmental Engineering, University of Sciences and Technology Houari Boumediene, Faculty of Mechanical and Process Engineering, El-Alia Bab-Ezzouar, B.P. 32, 16111, Algiers, Algeria

    Abderrazaq Hamdache

  3. Department of Material Science, Algiers University, 2 Didouche Mourad, 16000, Algiers, Algeria

    Lamia Grib, Celia Grib & Lydia Adour

  4. Analytical and Development Laboratory (LDA), Beker Laboratories, Dar El Beïda, 16033, Algiers, Algeria

    Hakim Zatout, Abderrahmane Mezrouai & Sarah Saraoui

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  1. Abderrazaq Hamdache
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  2. Lamia Grib
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  3. Celia Grib
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  4. Lydia Adour
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  6. Abderrahmane Mezrouai
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  7. Sarah Saraoui
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Correspondence to Abderrazaq Hamdache.

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Hamdache, A., Grib, L., Grib, C. et al. Forced Degradation Studies of Sofosbuvir with a Developed and Validated RP-HPLC Method as per ICH Guidelines. Chromatographia 84, 1131–1140 (2021). https://doi.org/10.1007/s10337-021-04099-8

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  • DOI: https://doi.org/10.1007/s10337-021-04099-8

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