UV-Spectrophotometric and Stability Indicating RP-HPLC Methods for the Determination of the Hepatitis C Virus Inhibitor Sofosbuvir in Tablet Dosage Form

References

• WHO Hepatitis C (2016). Fact Sheet no. 164.
   Google Scholar
• “FDA approves Sovaldi for chronic hepatitis C” (2013). FDA New Release. U.S. Food and Drug Administration.
   Google Scholar
• Product Monograph Pr SOVALDIR (sofosbuvir) Tablets 400 mg sofosbuvir Antiviral Agent (2016). Gilead Sciences Inc. Foster City, CA 94404 USA.
   Google Scholar
• Keating, G.M. (2014). Sofosbuvir: a review of its use in patients with chronic hepatitis C, Drugs. 74(10): 1127-46. doi: 10.1007/s40265-014-0247-z
   PubMed Web of Science ®Google Scholar
• Kirby, B.J., Symonds, W.T., Kearney, B.P., Mathias A.A. (2015). Pharmacokinetic, Pharmacodynamic, and Drug-Interaction Profile of the Hepatitis C Virus NS5B Polymerase Inhibitor Sofosbuvir. Clin. Pharmacokinet. 54(7): 677-90. doi: 10.1007/s40262-015-0261-7
   PubMed Web of Science ®Google Scholar
• Application for inclusion of sofosbuvir (SovaldiR) tablets on the WHO Model List of ssential Medicines (2014). Gilead Sciences, Inc. Foster City, CA.
   Google Scholar
• Hassouna, M.E.M., Abdelrahman, M.M., Mohamed, M.A. (2017). Assay and Dissolution Methods Development and Validation for Simultaneous Determination of Sofosbuvir and Ledipasvir by RP-HPLC Method in Tablet Dosage Forms. J Forensic Sci & Criminal Inves; 1(3): 1–11.
   Google Scholar
• European Pharmacopeia (2014). 8th edition.
   Google Scholar
• The United States Pharmacopoeia (2015). 38th Revision, NF 33, The United States Pharmacopoeia Convention Inc.
   Google Scholar
• British Pharmacopoeia, Stationary Office (2017). Medicines and Healthcare Products Regulatory Agency, London, Vol. II.
   Google Scholar
• Vikas, P.M., Satyanarayana, T., Kumar, D.V., Mounika, E., Sri, L.M., Sathish, Y. (2016). Development and validation of new RP-HPLC method for the determination of sofosbuvir in pure form. World Journal of Pharmacy and Pharmaceutical Sciences. 5(5): 775–781.
   Google Scholar
• Vejendla, R., Subramanyam, C.V.S., Veerabhadram, G. (2016). Estimation and validation of sofosbuvir in bulk and tablet dosage form by RP-HPLC, Int. J. Pharm. 6(2): 121–127.
   Google Scholar
• Swain, D., Samanthula, G., Bhagat, S., Bharatam, P.V., Akula, V., Sinha, B.N. (2016). Characterisation of forced degradation products and in silico toxicity prediction of Sofosbuvir: a novel HCV NS5B polymerase inhibitor. J. Pharm. Biomed. Anal. 120: 352–63. doi: 10.1016/j.jpba.2015.12.045
   PubMed Web of Science ®Google Scholar
• Nebsen, M., Elzanfaly, E.S. (2016). Stability-Indicating Method and LC-MS-MS Characterization of Forced Degradation Products of Sofosbuvir. Journal of Chromatographic Science. 1-10.
   Web of Science ®Google Scholar
• Rower, J.E., Jimmerson, L.C., Chen, X., Zheng, J.H., Hodara, A., Bushman, L.R., Anderson, P.L., Kiser, J.J. (2015). Validation and application of an LC-MS/MS method to determine the concentrations of sofosbuvir, Antimicrob. AgentsChemother. 59(12): 7671–9.
   Web of Science ®Google Scholar
• Rezk, M.R., Basalious, E.B., Amin, M.E. (2016). Novel and sensitive UPLC-MS/MS method for quantification of Sofosbuvir in human plasma: application to a bioequivalence study, Biomed. Chromatogr. 30: 1354–1362.
   Google Scholar
• Rower, J.E., Jimmerson, L.C., Chen, X., Zheng, J.H., Hodara, A., Bushman, L.R., Anderson, P.L., Kiser, J.J. (2015). Validation and Application of a Liquid Chromatography-Tandem Mass Spectrometry Method to Determine the Concentrations of Sofosbuvir Anabolites in Cells, Antimicrob Agents Chemother. 59(12): 7671–9. doi: 10.1128/AAC.01693-15
   PubMed Web of Science ®Google Scholar
• Rezk, M.R., Basalious, E.B., Karim, I.A. (2015). Development of a sensitive UPLCESI-MS/MS method for quantification of sofosbuvir and its metabolite, GS-331007, in human plasma: application to a bioequivalence study, J. Pharm. Biomed. Anal. 114: 97–104. doi: 10.1016/j.jpba.2015.05.006
   PubMed Web of Science ®Google Scholar
• Shi, X., Zhu, D., Lou, J., Zhu, B., Hu, A., Gan, D. (2015). Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS, Journal of Chromatography B Analytical Technologies in the Biomedical and Life Sciences. 1002: 353–357. doi: 10.1016/j.jchromb.2015.08.038
   PubMed Web of Science ®Google Scholar
• Kumar, B.R., Subrahmanyam, K.V. (2016). A New Validated RP-HPLC Method for the Determination of Simeprevir and Sofosbuvir in Pharmaceutical Dosage Form. Indo American Journal of Pharmaceutical Research. 6(02): 4508–4520.
   Google Scholar
• Elkady, E.F., Aboelwafa, A.A. (2016). A Rapid and Optimized LC-MS/MS Method for the Simultaneous Extraction and Determination of Sofosbuvir and Ledipasvir in Human Plasma. J AOAC Int. 99(5): 1252–1259. doi: 10.5740/jaoacint.16-0021
   PubMed Web of Science ®Google Scholar
• Rezk, M.R., Bendas, E.R., Basalious, E, Karim, I.A. (2016). Development and validation of sensitive and rapid UPLC-MS/MS method for quantitative determination of daclatasvir in human plasma: Application to a bioequivalence study. J. Pharm. Biomed. Anal. 128: 61–66. doi: 10.1016/j.jpba.2016.05.016
   PubMed Web of Science ®Google Scholar
• Rezk, M.R., Bendas, E.R., Basalious, E.B., Karim, I.A. (2016). Quantification of Sofosbuvir and ledipasvir in human plasma by UPLC-MS/MS method: Application to a bioequivalence study. Journal of Chromatography B. 128: 63–70. doi: 10.1016/j.jchromb.2016.06.004
   Google Scholar
• Ariaudo, A., Favata, F., NicolòA, De, Simiele, M., Paglietti, L., Boglione, L., Cardellino, C.S., Carcieri, C., Perri, GDi, D’Avolio, A.A. (2016). UHPLC-MS/MS method for the quantification of direct antiviral agents simeprevir, daclatasvir, ledipasvir, sofosbuvir/GS-331007, dasabuvir, ombitasvir and paritaprevir, together with ritonavir, in human plasma, Journal of Pharmaceutical and Biomedical Analysis. 125: 369–375. doi: 10.1016/j.jpba.2016.04.031
   PubMed Web of Science ®Google Scholar
• Pan, C., Chen, Y., Chen, W., Zhou, G., Jin, L., Zheng, Y., Lin, W., Pan, Z. (2016). Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study. Journal of Chromatography B. 1008: 255–259. doi: 10.1016/j.jchromb.2015.11.056
   PubMed Web of Science ®Google Scholar