Quantification of plasma levels of antiviral drug sofosbuvir and its metabolite GS331007 in patients of chronic hepatitis C with chronic kidney disease using UPLC-MS/MS method

Authors

  • Ruchi Singhala Department of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER), S.A.S Nagar, Punjab, India, 160062
  • Pramil Tiwaria Department of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER), S.A.S Nagar, Punjab, India, 160062
  • Ajay Dusejab Department of Hepatology, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012
  • Raja Ramachandranc Department of Nephrology, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012
  • Ajay Patiald Department of Biochemistry-Pediatrics, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012
  • Savita Attrid Department of Biochemistry-Pediatrics, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012

DOI:

https://doi.org/10.22270/ajprd.v8i1.659

Keywords:

sofosbuvir, GS331007, renal dysfunction, hemodialysis, UPLC-MS/MS

Abstract

Sofosbuvir based regimens are the only treatment available in India and some other Asian countries for curing hepatitis C viral (HCV) infection. The main excretion route of sofosbuvir is renal so treatment of HCV infection is challenging in patients on hemodialysis. A simple and sensitive UPLC-MS/MS method was developed and validated according to USFDA guidelines on Linear Ion trap Quadrupole tandem mass spectrometer (QTRAP4500) which was applied to estimate the drug concentration of sofosbuvir and its metabolite GS331007 in patients of chronic kidney disease with HCV infection. Clopidogrel was used as internal standard (IS) for this study. All analytes and IS were separated on UPLC C18-HSS column (2.1mmX50mm, 1.7μm) with retention time of 2.07, 0.29 and 1.58 min, respectively, by using mobile phases of 5mM ammonium acetate in 0.2% formic acid in water (A) and 5mM ammonium acetate in 0.2% formic acid in methanol (B) on gradient elution mode at a flow rate of 0.6 mL/min. Calibration curve was plotted over the range of 10-200 μg/mL for both of the analytes and equation was calculated by applying linear regression method. Detections of daughter ions (sofosbuvir-530 to 243m/z, GS331007-261 to 112.1m/z and clopidogrel- 322 to 154.9m/z) were done in multiple reactions monitoring (MRM) mode and weights were analyzed by using Linear ion trap quadrupole mass spectrometer with turbo spray ion source. The developed method has been successfully used for quantification of drug concentration of sofosbuvir and GS331007 to see the safety of sofosbuvir in patients of HCV infection with renal failures.

Downloads

Download data is not yet available.

Author Biographies

Ruchi Singhala, Department of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER), S.A.S Nagar, Punjab, India, 160062

Department of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER), S.A.S Nagar, Punjab, India, 160062

Pramil Tiwaria, Department of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER), S.A.S Nagar, Punjab, India, 160062

Department of Pharmacy Practice, National Institute of Pharmaceutical Education & Research (NIPER), S.A.S Nagar, Punjab, India, 160062

Ajay Dusejab, Department of Hepatology, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012

Department of Hepatology, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012

Raja Ramachandranc, Department of Nephrology, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012

Department of Nephrology, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012

Ajay Patiald, Department of Biochemistry-Pediatrics, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012

Department of Biochemistry-Pediatrics, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012

Savita Attrid, Department of Biochemistry-Pediatrics, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012

Department of Biochemistry-Pediatrics, Post Graduate Institute of Medical Education & Research (PGIMER), Chandigarh, India, 160012

References

1. Choo QL, Kuo G, Weiner AJ, et al., Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science. 1989;244(4902):359-62. https://doi.org/10.1126/science.2523562.
2. Mohd Hanafiah K, Groeger J, Flaxman AD, Wiersma ST, Global epidemiology of hepatitis C virus infection: new estimates of age-specific antibody to HCV seroprevalence. Hepatology. 2013;57(4):1333-42. https://doi.org/10.1002/hep.26141.
3. Messina JP, Humphreys I, Flaxman A, et al., Global distribution and prevalence of hepatitis C virus genotypes. Hepatology. 2015;61(1):77-87. https://doi.org/10.1002/hep.27259.
4. Ly KN, Xing J, Klevens RM, et al., The increasing burden of mortality from viral hepatitis in the United States between 1999 and 2007. Ann Intern Med. 2012;156(4):271-8. https://doi.org/10.7326/0003-4819-156-4-201202210-00004.
5. Cacoub P, Poynard T, Ghillani P, et al., Extrahepatic manifestations of chronic hepatitis C. MULTIVIRC Group. Multidepartment Virus C. Arthritis Rheum. 1999;42(10):2204-12. https://doi.org/10.1002/529-0131(199910)42:10<2204:AID-ANR24>3.0.CO;2-D.
6. Cacoub P, Gragnani L, Comarmond C, Zignego AL, Extrahepatic manifestations of chronic hepatitis C virus infection. Dig Liver Dis. 2014;15(46):8. https://doi.org/10.1016/j.dld.2014.10.005.
7. Finelli L, Miller JT, Tokars JI, Alter MJ, Arduino MJ, National surveillance of dialysis-associated diseases in the United States, 2002. Semin Dial. 2005;18(1):52-61. https://doi.org/10.1111/j.525-139X.2005.18108.x.
8. Fissell RB, Bragg-Gresham JL, Woods JD, et al., Patterns of hepatitis C prevalence and seroconversion in hemodialysis units from three continents: the DOPPS. Kidney Int. 2004;65(6):2335-42. https://doi.org/10.1111/j.523-755.2004.00649.x.
9. Jadoul M, Poignet JL, Geddes C, et al., The changing epidemiology of hepatitis C virus (HCV) infection in haemodialysis: European multicentre study. Nephrol Dial Transplant. 2004;19(4):904-9. https://doi.org/10.1093/ndt/gfh012.
10. Nakayama E, Akiba T, Marumo F, Sato C, Prognosis of anti-hepatitis C virus antibody-positive patients on regular hemodialysis therapy. J Am Soc Nephrol. 2000;11(10):1896-902.
11. Fabrizi F, Martin P, Dixit V, Bunnapradist S, Dulai G, Meta-analysis: Effect of hepatitis C virus infection on mortality in dialysis. Aliment Pharmacol Ther. 2004;20(11-12):1271-7. https://doi.org/10.111/j.365-2036.04.02290.x.
12. Legendre C, Garrigue V, Le Bihan C, Harmful long-term impact of hepatitis C virus infection in kidney transplant recipients. Transplantation. 1998;65(5):667-70. https://doi.org/10.1097/00007890-199803150-00011.
13. Fabrizi F, Dixit V, Messa P, Hepatitis C virus and mortality among patients on dialysis: A systematic review and meta-analysis. Clin Res Hepatol Gastroenterol. 2019;43(3):244-54. https://doi.org/10.1016/j.clinre.2018.10.009.
14. Aguirre Valadez J, Garcia Juarez I, Rincon Pedrero R, Torre A, Management of chronic hepatitis C virus infection in patients with end-stage renal disease: a review. Ther Clin Risk Manag. 2015;11:329-38. https://doi.org/10.2147/TCRM.S74282.
15. Mucke MM, Mucke VT, Lange CM, Zeuzem S, Special populations: treating hepatitis C in patients with decompensated cirrhosis and/or advanced renal impairment. Liver Int. 2017;1:19-25. https://doi.org/10.1111/liv.13279.
16. Hull MW, Yoshida EM, Montaner JS, Update on Current Evidence for Hepatitis C Therapeutic Options in HCV Mono-infected Patients. Curr Infect Dis Rep. 2016;18(7):016-0527. https://doi.org/10.1007/s11908-8.
17. Kirby BJ, Symonds WT, Kearney BP, Mathias AA, Pharmacokinetic, Pharmacodynamic, and Drug-Interaction Profile of the Hepatitis C Virus NS5B Polymerase Inhibitor Sofosbuvir. Clin Pharmacokinet. 2015;54(7):677-90. https://doi.org/10.1007/s40262-015-0261-7.
18. SOVALDI® (sofosbuvir), Gilead sciences. Hayes, UK: Food & Drug Administration; 2015 [cited September 2016]; Available from: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/204671s004lbl.pdf.
19. Smolders EJ, de Kanter CT, van Hoek B, et al., Pharmacokinetics, Efficacy, and Safety of Hepatitis C Virus Drugs in Patients with Liver and/or Renal Impairment. Drug Saf. 2016;39(7):589-611. https://doi.org/10.1007/s40264-016-0420-2.
20. Abdallah OM, Abdel-Megied AM, Gouda AS, Development and validation of LC-MS/MS method for simultaneous determination of sofosbuvir and daclatasvir in human Plasma: Application to pharmacokinetic study. Biomed Chromatogr. 2018;32(6):29. https://doi.org/10.1002/bmc.4186.
21. Pan C, Chen Y, Chen W, et al., Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS and its application to a pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2016;1:255-9. https://doi.org/10.1016/j.jchromb.2015.11.056.
22. Shi X, Zhu D, Lou J, et al., Evaluation of a rapid method for the simultaneous quantification of ribavirin, sofosbuvir and its metabolite in rat plasma by UPLC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2015;1:353-7. https://doi.org/10.1016/j.jchromb.2015.08.038.
23. van Seyen M, de Graaff Teulen MJA, van Erp NP, Burger DM, Quantification of second generation direct-acting antivirals daclatasvir, elbasvir, grazoprevir, ledipasvir, simeprevir, sofosbuvir and velpatasvir in human plasma by UPLC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2019;15:1110-1. https://doi.org/10.016/j.jchromb.2019.01.024.
24. Elkady EF, Aboelwafa AA, A Rapid and Optimized LC-MS/MS Method for the Simultaneous Extraction and Determination of Sofosbuvir and Ledipasvir in Human Plasma. J AOAC Int. 2016;99(5):1252-9. https://doi.org/10.5740/jaoacint.16-0021.
25. Ferrari D, Bagaglio S, Raso M, et al., A liquid chromatography-tandem mass spectrometry method for simultaneous determination of simeprevir, daclatasvir, sofosbuvir, and GS-331007 applied to a retrospective clinical pharmacological study. J Chromatogr B Analyt Technol Biomed Life Sci. 2019;1:1-7. https://doi.org/10.1016/j.jchromb.2019.04.048.
26. Rezk MR, Bendas ER, Basalious EB, Karim IA, 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. 2016;128:61-6. https://doi.org/10.1016/j.jpba.2016.05.016.
27. Rezk MR, Basalious EB, Karim IA, Development of a sensitive UPLC-ESI-MS/MS method for quantification of sofosbuvir and its metabolite, GS-331007, in human plasma: Application to a bioequivalence study. J Pharm Biomed Anal. 2015;114:97-104. https://doi.org/10.1016/j.jpba.2015.05.006.
28. Rezk MR, Basalious EB, Amin ME, Novel and sensitive UPLC-MS/MS method for quantification of sofosbuvir in human plasma: application to a bioequivalence study. Biomed Chromatogr. 2016;30(9):1354-62. https://doi.org/10.002/bmc.3690.
29. U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Bioanalytical Method validation. Guidance for industry. Available from: https://www.fda.gov/media/70858/download.
30. Desnoyer A, Pospai D, Le MP, et al., Pharmacokinetics, safety and efficacy of a full dose sofosbuvir-based regimen given daily in hemodialysis patients with chronic hepatitis C. J Hepatol. 2016;65(1):40-7. https://doi.org/10.1016/j.jhep.2016.02.044.

Published

2020-02-15

How to Cite

Singhala, R., Tiwaria, P., Dusejab, A., Ramachandranc, R., Patiald, A., & Attrid, S. (2020). Quantification of plasma levels of antiviral drug sofosbuvir and its metabolite GS331007 in patients of chronic hepatitis C with chronic kidney disease using UPLC-MS/MS method. Asian Journal of Pharmaceutical Research and Development, 8(1), 59–66. https://doi.org/10.22270/ajprd.v8i1.659