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Current Pharmaceutical Analysis

Editor-in-Chief

ISSN (Print): 1573-4129
ISSN (Online): 1875-676X

Research Article

A Novel Simultaneous Estimation of Sofosbuvir and Velpatasvir in Human Plasma by Liquid Chromatography Tandem-Mass Spectrometry after Protein Precipitation Method

Author(s): S.T. Narenderan , Basuvan Babu*, T. Gokul and Subramania Nainar Meyyanathan

Volume 15, Issue 7, 2019

Page: [710 - 715] Pages: 6

DOI: 10.2174/1573412914666180910102353

Price: $65

Abstract

Objective: The aim of the present work is to achieve a novel highly sensitive chromatographic method for the simultaneous determination of hepatitis C agents, sofosbuvir and velpatasvir from human plasma using ritonavir as an internal standard.

Methods: Chromatographic separation was achieved using Hypersil C18 column (50mm x 4.6mm, 3μm) with an isocratic elution mode using the mobile phase composition 10 mM ammonium formate buffer (pH 5.0): acetonitrile (20:80 v/v) pumped at a flow rate of 0.5 ml/min. The detection was carried out by tandem mass spectrometry using Multiple Reaction Monitoring (MRM) positive Electrospray Ionization (ESI) with proton adducts at m/z 530.10 > 243.10, 883.40 > 114.0 and 721.25 > 197.0.

Results: The method validated as per USFDA guidelines with respect to linearity, accuracy, and precision was found to be acceptable over the concentration range of 0.2–2000 ng/ml and 5-2000 ng/ml for sofosbuvir and velpatasvir respectively and the method was found to be highly sensitive and selective.

Conclusion: The developed tandem mass spectrometric method is robust and can be applied for the monitoring of plasma levels of the analyzed drug in preclinical and clinical pharmacokinetic studies.

Keywords: Hepatitis C, human plasma, sofosbuvir, velpatasvir, US-FDA, virus.

Graphical Abstract

[1]
Ghany, M.G.; Strader, D.B.; Thomas, D.L.; Seeff, L.B. Diagnosis, management, and treatment of hepatitis C: an update. Hepatology, 2009, 49(4), 1335-1374.
[2]
Naggie, S.; Patel, K.; McHutchison, J. Hepatitis C virus directly acting antivirals: current development with NS3/4A HCV serine protease inhibitors. J. Antimicrob. Chemother., 2010, 65(10), 2063-2069.
[3]
Hep database. https://www.hepmag.com (Accessed on: 08 July 2017) .
[4]
FDA Approved drug products: sofosbuvir and velpatasvir. https://www.accessdata.fda.gov (Accessed on: 15 July 2017) .
[5]
Shi, X.; Zhu, D.; Lou, J.; Zhu, B.; Hu, A.R.; Gan, D. 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 ., 2015, 1002, 353-357.
[6]
Salama, F.M.; Attia, K.A.; Abouserie, A.A.; El-Olemy, A.; Abolmagd, E. Spectroflurimetric estimation of the new antiviral agent ledipasvir in presence of sofosbuvir. Spectrochim. Acta part A ., 2017, 190, 513-517.
[7]
Baker, M.M.; El-Kafrawy, D.S.; Mahrous, M.S.; Belal, T.S. Validated spectrophotometric and chromatographic methods for analysis of the recently approved hepatitis C antiviral combination ledipasvir and sofosbuvir. Ann. Pharm. Fr., 2018, 76(1), 16-31.
[8]
Mansour, F.R. A new innovative spectrophotometric method for the simultaneous determination of sofosbuvir and ledipasvir. Spectrochim. Acta part A., 2017, 188, 626-632.
[9]
Rezk, M.R.; Bendas, E.R.; Basalious, E.B.; Karim, I.A. Quantification of sofosbuvir and ledipasvir in human plasma by UPLC-MS/MS method: application to fasting and fed bioequivalence studies. J. Chromatogr. B ., 2016, 1028, 63-70.
[10]
Ariaudo, A.; Favata, F.; De Nicolò, A.; Simiele, M.; Paglietti, L.; Boglione, L.; Cardellino, C.S.; Carcieri, C.; Di Perri, A.G.; D’Avolio, A.A. 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. J. Pharm. Biomed. Anal., 2016, 125, 369-375.
[11]
Abdallah, O.M.; Abdel-Megied, A.M.; Gouda, A.S. Development a validated highly sensitive LC-MS/MS method for simultaneous quantification of Ledipasvir, sofosbuvir and its major metabolite GS-331007 in human plasma: application to a human pharmacokinetic study. J. Pharm. Biomed. Anal., 2017, 143, 305-310.
[12]
Shi, X.; Zhu, D.; Lou, J.; Zhu, B.; Hu, A.R.; Gan, D. 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 ., 2015, 1002, 353-357.
[13]
Pan, C.; Chen, Y.; Chen, W.; Zhou, G.; Jin, L.; Zheng, Y.; Lin, W.; Pan, Z. Simultaneous determination of ledipasvir, sofosbuvir and its metabolites in rat plasma by UPLC–MS/MS and its application to a pharmacokinetic study. J. Chromatogr. B , 2016, 1008, 255-259.
[14]
Rezk, M.R.; Basalious, E.B.; Karim, I.A. 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.
[15]
USFDA-Draft Guidance for industry-analytical procedures and methods validation for drugs and biologics. Feb. 2014 (Accessed on: 20 July 2017).

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