Potential of RP-UHPLC-DAD-MS for the qualitative and quantitative analysis of sofosbuvir in film coated tablets and profiling degradants

Sofosbuvir is one of the new direct-acting antiviral drugs against hepatitis C virus (HCV) infection. This drug has recently been launched into the market, and generic versions of the medication are expected to be produced by local drug producers in some countries. Therefore, new methods are require...

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Bibliographic Details
Published in:Journal of pharmaceutical analysis 2017-08, Vol.7 (4), p.208-213
Main Authors: Contreras, María Del Mar, Morales-Soto, Aránzazu, Segura-Carretero, Antonio, Valverde, Javier
Format: Article
Language:English
Subjects:
Antiviral agents
Chromatography
coated
Drug dosages
Film coated tablets
Hepatitis
Hepatitis C
High-performance liquid chromatography
Impurities
Infections
Ions
Mass spectrometry
Mass spectroscopy
Methods
Original
Pharmaceutical industry
Quantitative analysis
RNA polymerase
RP-UHPLC
Scientific imaging
Sofosbuvir
spectrometry
RP-UHPLC
Sofosbuvir
Studies
Tablets
tablets
Mass
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Summary:Sofosbuvir is one of the new direct-acting antiviral drugs against hepatitis C virus (HCV) infection. This drug has recently been launched into the market, and generic versions of the medication are expected to be produced by local drug producers in some countries. Therefore, new methods are required to control sofosbuvir in pharmaceuticals. In the present study, a new method based on reversed phase (RP)-ultra-high performance liquid chromatography (UHPLC) coupled to diode array detection (DAD) and mass spectrometry (MS) was developed to facilitate the qualitative and quantitative analysis of sofosbuvir in film coated tablets. A wavelength of 260 nm was selected to perform a cost-effective quantification and the method showed adequate linearity,with an R2 value of 0.9998, and acceptable values of accuracy (75%–102%) and precision (residual standard deviation < 5%). The detection and quantification limits were 0.07 μg/mL and 0.36 μg/mL, respectively.Furthermore, the use of high-resolution MS enabled us to ensure the specificity, check impurities and better sensitivity. Therefore, this methodology promises to be suitable not only for the routine analysis of sofosbuvir in pharmaceutical dosage forms, but also for potential degradants.
ISSN:2095-1779
2214-0883
DOI:10.1016/j.jpha.2017.04.003