Validation of RP-HPLC Method for Determination of Sofosbuvir in Bulk and Pharmaceutical Dosage Forms

DOI:

https://doi.org/10.37285/ijpsn.2020.13.2.4

Authors

  • Abrar Ahmed
  • Tayyaba Mahtab
  • Sumaiyya Saleem
  • Srinivas Akula
  • Mohammed Dilawar Khan

Abstract

A simple, accurate, economic and precise RP-HPLC method was developed to determine sofosbuvir in bulk and tablet dosage form and validated following the ICH guidelines for various parameters such as precision, linearity, accuracy, specificity and robustness. Sofosbuvir is used to treat viral diseases such as Hepatitis-C.  The detection was carried out Agilent Eclipse® XDB-C18, 5µm 4.6×250 mm column using gradient composition of 0.03M KH2PO4 in 1000 ml of water adjusted to a pH of 2.5 with dilute orthphosphoric acid. A flow rate of 1ml/minute with detection wavelength at 260 nm was used. Retention time was found to be 3.166 and the linearity of this method was observed over the range of 40-240 µg/ml. The linear regression equation from the linearity study was Y = 32036x + 75288. Limit of detection (LOD) and limit of quantitation (LOQ) was 0.02 µg/ml and 0.06 µg/ml respectively. The assay percent of sofosbuvir was found to be 109.6% whereas percentage recovery of sofosbuvir for average of three concentrations was 96.51%. This confirms the high accuracy of the assay method. In conclusion, the validated method can be used to analyze the marketed formulations. 

 

Downloads

Download data is not yet available.

Metrics

Metrics Loading ...

Keywords:

Sofosbuvir, HPLC, Accuracy, ICH guidelines

Downloads

Published

2020-03-31

How to Cite

1.
Ahmed A, Mahtab T, Saleem S, Akula S, Khan MD. Validation of RP-HPLC Method for Determination of Sofosbuvir in Bulk and Pharmaceutical Dosage Forms. Scopus Indexed [Internet]. 2020 Mar. 31 [cited 2024 Nov. 19];13(2):4826-30. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/259

Issue

Vol. 13 No. 2 (2020): March-April 2020

Section

Research Articles
Crossref
Scopus
Google Scholar
Europe PMC

References

Asselah T (2014). Sofosbuvir for the treatment of hepatitis C virus. Expert opinion on pharmacotherapy 15(1):121-130.
Cope R, Pickering A, Glowa T, Faulds S, Veldkamp P, and Prasad R (2015). Majority of HIV/HCV patients need to switch antiretroviral therapy to accommodate direct acting antivirals. AIDS patient care and STDs 29(7): 379-383.
Denning J, Cornpropst M, Flach SD, Berrey MM, and Symonds WT (2013). Pharmacokinetics, safety, and tolerability of GS-9851, a nucleotide analog polymerase inhibitor for hepatitis C virus, following single ascending doses in healthy subjects. Antimicrobial agents and chemotherapy 57(3):1201-1208.
Fontaine H, Lazarus A, Pol S, Pecriaux C, Bagate F, Sultanik P, Boueyre E, Corouge M, Mallet V, Vallet-Pichard A, and Sogni P (2015). Bradyarrhythmias Associated with Sofosbuvir Treatment. The New England journal of medicine 373(19):1886.
Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, Hindes RG, and Berrey MM (2013). Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. New England Journal of Medicine 368(1): 34-44.
ICH Q2B guideline (1996), Validation of Analytical Procedures: Methodology, Guidance for Industry, 1-10.
Kirby BJ, Symonds WT, Kearney BP, and Mathias AA (2015). Pharmacokinetic, pharmacodynamic, and drug-interaction profile of the hepatitis C virus NS5B polymerase inhibitor sofosbuvir. Clinical Pharmacokinetics 54(7): 677-690.
Marcel Nkuize, Thomas Serste MS, and Jean-Pierre M (2016). Combination ledipasvir-sofosbuvir for the treatment of chronic hepatitis C virus infection: a review and clinical perspective. Their Clin Risk Manag 12: 861-872.
Raj Kumar B and KV Subrahmanyam (2016). A new validated RP-HPLC method for the simultaneous determination of simeprevir and sofobuvir in pharmaceutical dosage form. Indo Am J Pharm Sci 5:4508-4520.
Ravikumar V and CVS Subramanyam (2016). Estimation and validation of sofosbuvir in bulk and tablet dosage form by RPHPLC. Int J Pharm 6:121-127.
Uttam Prasad Panigraphy, and Sunil Kumar Reddy (2016). A novel validated RP-HPLC method for the simultaneous estimation of atazanavir sulphate and cobicistat in bulk and pharmaceutical dosage form. Int J Pharm Sci Rev Res 36: 82-89.
Van de Ven N, Fortunak J, Simmons B, Ford N, Cooke GS, Khoo S, and Hill A (2015). Minimum target prices for production of direct‐acting antivirals and associated diagnostics to combat hepatitis C virus. Hepatology 61(4):1174-1182.
Younossi ZM, Stepanova M, Henry L, Gane E, Jacobson IM, Lawitz E, Nelson D, Gerber L, Nader F and Hunt S (2014). Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C. Clinical Gastroenterology and Hepatology 12(8):1349-1359.