Login Register Cart 0
Generic placeholder image

Current Analytical Chemistry

Editor-in-Chief

ISSN (Print): 1573-4110
ISSN (Online): 1875-6727

Back
Journal Home About Journal Editorial Board Journal Insight Current Issue Volumes/Issues
Subscribe
Research Article

Development and Validation of a New Method for the Determination of Anti-hepatitis C Agent Simeprevir in Human Plasma using HPLC with Fluorescence Detection

Author(s): Ahmed F.A. Youssef*, Yousry M. Issa and Kareem M. Nabil

Volume 16, Issue 4, 2020

Page: [428 - 435] Pages: 8

DOI: 10.2174/1573411015666181217121619

Price: $65

Abstract

Background: Simeprevir is one of the recently discovered drugs for treating hepatitis C which is one of the major diseases across the globe.

Objective: The present study involves the development of a new and unique High-Performance Liquid Chromatography (HPLC) method using fluorescence detection for the determination of simeprevir (SIM) in human plasma.

Methods: Two methods of extractions were tested, protein precipitation using acetonitrile and liquidliquid extraction. A 25 mM dipotassium hydrogen orthophosphate (pH 7.0)/ACN (50/50; v/v), was used as mobile phase and C18 reversed phase column as the stationary phase. The chromatographic conditions were optimized and the concentration of simeprevir was determined by using the fluorescence detector. Cyclobenzaprine was used as an internal standard.

Results: Recovery of the assay method based on protein precipitation was up to 100%. Intra-day and inter-day accuracies range from 92.30 to 107.80%, with Relative Standard Deviation (RSD) range 1.65-8.02%. The present method was successfully applied to a pharmacokinetic study where SIM was administered as a single dose of 150 mg SIM/capsule (Olysio®) to healthy individuals.

Conclusion: This method exhibits high sensitivity with a low limit of quantification 10 ng mL-1, good selectivity using fluorescence detection, wide linear application range 10-3000 ng mL-1, good recovery and highly precise and validation results. The developed method can be applied in routine analysis for real samples.

Keywords: Fluorescence, HPLC, human plasma, method development, simeprevir, validation.

« Previous Next »
Graphical Abstract

[1]
Tan, S.L. Hepatitis C Viruses: Genomes and Molecular Biology; Horizon Bioscience: U.K, 2006.
[2]
Hézode, C.; Fontaine, H.; Dorival, C.; Larrey, D.; Zoulim, F.; Canva, V.; de Ledinghen, V.; Poynard, T.; Samuel, D.; Bourlière, M.; Zarski, J.P.; Raabe, J.J.; Alric, L.; Marcellin, P.; Riachi, G.; Bernard, P.H.; Loustaud-Ratti, V.; Métivier, S.; Tran, A.; Serfaty, L.; Abergel, A.; Causse, X.; Di Martino, V.; Guyader, D.; Lucidarme, D.; Grando-Lemaire, V.; Hillon, P.; Feray, C.; Dao, T.; Cacoub, P.; Rosa, I.; Attali, P.; Petrov-Sanchez, V.; Barthe, Y.; Pawlotsky, J.M.; Pol, S.; Carrat, F.; Bronowicki, J.P. CUPIC Study Group. Triple therapy in treatment-experienced patients with HCV-cirrhosis in a multicentre cohort of the French Early Access Programme (ANRS CO20-CUPIC) - NCT01514890. J. Hepatol., 2013, 59(3), 434-441.
[http://dx.doi.org/10.1016/j.jhep.2013.04.035] [PMID: 23669289]
[3]
Zeuzem, S.; Hézode, C.; Bronowicki, J.P.; Loustaud-Ratti, V.; Gea, F.; Buti, M.; Olveira, A.; Banyai, T.; Al-Assi, M.T.; Petersen, J.; Thabut, D.; Gadano, A.; Pruitt, R.; Makara, M.; Bourlière, M.; Pol, S.; Beumont-Mauviel, M.; Ouwerkerk-Mahadevan, S.; Picchio, G.; Bifano, M.; McPhee, F.; Boparai, N.; Cheung, K.; Hughes, E.A.; Noviello, S. LEAGUE-1 Study Team. Daclatasvir plus simeprevir with or without ribavirin for the treatment of chronic hepatitis C virus genotype 1 infection. J. Hepatol., 2016, 64(2), 292-300.
[http://dx.doi.org/10.1016/j.jhep.2015.09.024] [PMID: 26453968]
[4]
Sulkowski, M.S.; Vargas, H.E.; Di Bisceglie, A.M.; Kuo, A.; Reddy, K.R.; Lim, J.K.; Morelli, G.; Darling, J.M.; Feld, J.J.; Brown, R.S.; Frazier, L.M.; Stewart, T.G.; Fried, M.W.; Nelson, D.R.; Jacobson, I.M. HCV-TARGET Study Group. Effectiveness of simeprevir plus sofosbuvir, with or without ribavirin, in real-world patients with HCV Genotype 1 Infection. Gastroenterology, 2016, 150(2), 419-429.
[http://dx.doi.org/10.1053/j.gastro.2015.10.013] [PMID: 26497081]
[5]
Vanwelkenhuysen, I.; de Vries, R.; Timmerman, P.; Verhaeghe, T. Determination of simeprevir: a novel, hepatitis C protease inhibitor in human plasma by high-performance liquid chromatography-tandem mass spectrometry. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2014, 958, 43-47.
[http://dx.doi.org/10.1016/j.jchromb.2014.02.028] [PMID: 24695212]
[6]
Ariaudo, A.; Favata, F.; De Nicolò, A.; Simiele, M.; Paglietti, L.; Boglione, L.; Cardellino, C.S.; Carcieri, C.; Di Perri, 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.
[http://dx.doi.org/10.1016/j.jpba.2016.04.031] [PMID: 27131146]
[7]
Nannetti, G.; Pagni, S.; Parisi, S.G.; Alberti, A.; Loregian, A.; Palù, G. Development of a simple HPLC-UV method for the determination of the hepatitis C virus inhibitor simeprevir in human plasma. J. Pharm. Biomed. Anal., 2016, 121, 197-203.
[http://dx.doi.org/10.1016/j.jpba.2016.01.019] [PMID: 26808069]
[8]
FDA US. Guidance for Industry Bioanalytical Method Validation; Department of Health and Human Services: Rockville, MD, USA, 2001.
[9]
Ranjan, O.P.; Nayak, U.Y.; Reddy, M.S.; Dengale, S.J.; Musmade, P.B.; Udupa, N. Development and validation of RP-HPLC method with ultraviolet detection for estimation of montelukast in rabbit plasma: Application to preclinical pharmacokinetics. J. Young Pharm., 2013, 5(4), 133-138.
[http://dx.doi.org/10.1016/j.jyp.2013.10.006] [PMID: 24563591]
[10]
Hefnawy, M.M.; Alanazi, A.M.; Abounassif, M.A.; Mohammed, M.S.; Attia, S.M.; Mostafa, G.A.E. Validated liquid chromatographic-fluorescence method for the quantitation of darifenacin in mice plasma and its application to a pharmacokinetic study. Talanta, 2014, 121, 37-42.
[http://dx.doi.org/10.1016/j.talanta.2013.10.037] [PMID: 24607107]
[11]
Pathak, S.M.; Kumar, A.R.; Musmade, P.; Udupa, N. A simple and rapid high performance liquid chromatographic method with fluorescence detection for the estimation of fexofenadine in rat plasma--application to preclinical pharmacokinetics. Talanta, 2008, 76(2), 338-346.
[http://dx.doi.org/10.1016/j.talanta.2008.02.047] [PMID: 18585287]
[12]
Khan, I.; Iqbal, Z.; Khan, A.; Hassan, M.; Nasir, F.; Raza, A.; Ahmad, L.; Khan, A.; Akhlaq Mughal, M. A simple, rapid and sensitive RP-HPLC-UV method for the simultaneous determination of sorafenib & paclitaxel in plasma and pharmaceutical dosage forms: Application to pharmacokinetic study. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci., 2016, 1033-1034, 261-270.
[http://dx.doi.org/10.1016/j.jchromb.2016.08.029] [PMID: 27592284]
[13]
Majdi, M.B. Simultaneous Determination of simvastatin with caffeine in bulk drug, formulation and their monitoring in mice plasma through HPLC-PDA Technique. Curr. Anal. Chem., 2017, 13, 6.
[14]
Rower, J.E.; Bushman, L.R.; Hammond, K.P.; Kadam, R.S.; Aquilante, C.L. Validation of an LC/MS method for the determination of gemfibrozil in human plasma and its application to a pharmacokinetic study. Biomed. Chromatogr., 2010, 24(12), 1300-1308.
[http://dx.doi.org/10.1002/bmc.1440] [PMID: 21077249]

Rights & Permissions Print Cite
Article Metrics
13
© 2024 Bentham Science Publishers | Privacy Policy