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

María del Mar Contreras; Aránzazu Morales-Soto; Antonio Segura-Carretero; Javier Valverde

Volume 7 Issue 4

Aug. 2017

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Article Navigation > Journal of Pharmaceutical Analysis > 2017 > 7(4): 208-213

María del Mar Contreras, Aránzazu Morales-Soto, Antonio Segura-Carretero, Javier Valverde. Potential of RP-UHPLC-DAD-MS for the qualitative and quantitative analysis of sofosbuvir in film coated tablets and profiling degradants[J]. Journal of Pharmaceutical Analysis, 2017, 7(4): 208-213.

Citation:

María del Mar Contreras, Aránzazu Morales-Soto, Antonio Segura-Carretero, Javier Valverde. Potential of RP-UHPLC-DAD-MS for the qualitative and quantitative analysis of sofosbuvir in film coated tablets and profiling degradants[J]. Journal of Pharmaceutical Analysis, 2017, 7(4): 208-213.

Citation:

María del Mar Contreras, Aránzazu Morales-Soto, Antonio Segura-Carretero, Javier Valverde. Potential of RP-UHPLC-DAD-MS for the qualitative and quantitative analysis of sofosbuvir in film coated tablets and profiling degradants[J]. Journal of Pharmaceutical Analysis, 2017, 7(4): 208-213.

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

Department of Analytical Chemistry, Faculty of Sciences, University of Granada, Avenida Fuentenueva s/n, 18071 Granada, Spain
Research and Development Functional Food Centre (CIDAF), Bioregión Building, Health Science Technological Park, Avda. Del Conocimiento s/n, 18016 Granada, Spain

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The authors thank Medical Cables Company for providing us with the samples (Sofolanork tablets). A. Morales-Soto acknowledges the postdoctoral contract co-financed by the Spanish Ministry of Economy and Competiveness, and the Andalusian Regional Gove

Publish Date: Aug. 10, 2017

Abstract

Abstract

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.
- Film coated tablets,
- Mass spectrometry,
- RP-UHPLC,
- Sofosbuvir

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