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Spectrophotometric assessment of the brand new antiviral combination: Sofosbuvir and velpatasvir in their pure forms and pharmaceutical formulation.

Authors
  • Rezk, Mamdouh R1
  • Monir, Hany H1
  • Marzouk, Hoda M2
  • 1 Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt. , (Egypt)
  • 2 Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, Kasr El-Aini Street, 11562 Cairo, Egypt. Electronic address: [email protected] , (Egypt)
Type
Published Article
Journal
Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy
Publication Date
Apr 15, 2019
Volume
213
Pages
159–166
Identifiers
DOI: 10.1016/j.saa.2019.01.058
PMID: 30685554
Source
Medline
Keywords
Language
English
License
Unknown

Abstract

Sofosbuvir (SOF) and velpatasvir (VEL) are recently co-formulated together for the treatment of hepatitis C virus. Smart and robust spectrophotometric methods were first developed and validated for quantification of SOF and VEL in their pure forms and in their combined pharmaceutical formulation without preliminary separation. VEL has two UV maxima at 302.5 and 337.0 nm that allow its direct determination by zero-order spectrophotometric method (D°) without any interference from SOF in a linear range of 2.0-30.0 μg/mL. On the other hand, determination of SOF in presence of VEL was carried out by four smart spectrophotometric methods, developed for resolving the overlaid spectra of these binary mixture. These methods are dual wavelength (DW), ratio subtraction (RS), ratio difference (RD) and first derivative of ratio spectra method (1DD). Linearity was checked and found to be in the range of 5.0-90.0 μg/mL for SOF by all of the aforementioned spectrophotometric methods. The developed methods were optimized and validated in accordance to the ICH guidelines. They were successfully utilized for estimating both SOF and VEL in their pure forms, laboratory prepared mixtures and in their pharmaceutical formulations with good recoveries. The methods can be easily applied for the routine analysis in quality control laboratories. Copyright © 2019 Elsevier B.V. All rights reserved.

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