European Journal of Chemistry 2016, 7(3), 375-379 | doi: https://doi.org/10.5155/eurjchem.7.3.375-379.1439 | Get rights and content






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Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms


Sherif Abdel-Naby Abdel-Gawad (1,*)

(1) Pharmaceutical Chemistry Department, Collage of Pharmacy, Prince Sattam Bin-Abdul Aziz University, Al-Kharj, 119924, Kingdom of Saudi Arabia
(*) Corresponding Author

Received: 14 Apr 2016 | Accepted: 07 May 2016 | Published: 30 Sep 2016 | Issue Date: September 2016

Abstract


Two methods, a reversed phase high-performance liquid chromatographic (RP-HPLC) method and a direct ultra-violet spectrophotometric method, were adopted and validated for the quantification of sofosbuvir, which is a new antiviral agent used for treatment of patients with hepatitis C virus (HCV). Validation parameters such as linearity, accuracy, precision, specificity, limits of detection and quantification were determined according to the guidelines of International Conference on Harmonization (ICH)-Q2B. The RP-HPLC method was applied on HypersilTM ODS C18 column (150×4.6 mm, 5 µm) as a stationary phase. The mobile phase was optimized according to the polarity of the studied drug. It was methanol: acetonitrile (90:10, v:v), pumped using an isocratic mode with flow rate of 1 mL/min and UV detection at 260 nm. The UV spectrophotometric method was performed for the studied drug at 260 nm. The calibration curves were linear in the ranges of 2-60 µg/mL and 5-40 µg/mL for the RP-HPLC and UV spectrophotometric methods, respectively. The proposed methods are accurate, sensitive and precise, so they can be successfully adopted for the reliable determination of sofosbuvir content in its tablet form.


Keywords


RP-HPLC; Validation; Sofosbuvir; Antiviral drug; Analytical methods; UV/Vis spectroscopy

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DOI: 10.5155/eurjchem.7.3.375-379.1439

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Funding information


Collage of Pharmacy, Prince Sattam Bin-Abdul Aziz University, Al-Kharj, 119924, Kingdom of Saudi Arabia

Citations

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[1]. Dalia W. Zidan, Wafaa S. Hassan, Manal S. ElMasry, Abdalla A. Shalaby
Novel spectrophotometric and factor-based multivariate calibration-prediction techniques for determination of two inhibitors of hepatitis C-virus and hepatocellular carcinoma in pure, human urine, and human plasma
Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy  213, 288, 2019
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[2]. Rania M. El-Gamal, Sherif A. Abdel-Gawad, Fathalla F. Belal, Moustapha E. Moustapha
Selective and sensitive spectrofluorimetric quantification of velpatasvir in presence of sofosbuvir. Application to their co-formulated tablet
RSC Advances  8(57), 32909, 2018
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[3]. Sherif Abdel-Naby Abdel-Gawad
Validated simultaneous spectrophotometric quantification of a new antiviral combination
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[4]. Aya A Youssef, N Magdy, Lobna A Hussein, A M El-Kosasy
Validated RP-HPLC Method for Simultaneous Determination of Ribavirin, Sofosbuvir and Daclatasvir in Human Plasma: A Treatment Protocol Administered to HCV Patients in Egypt
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[5]. Roshdy E. Saraya, Magda Elhenawee, Hanaa Saleh
Development of a highly sensitive high-performance thin-layer chromatography method for the screening and simultaneous determination of sofosbuvir, daclatasvir, and ledipasvir in their pure forms and their different pharmaceutical formulations
Journal of Separation Science  41(18), 3553, 2018
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[6]. Moustapha Eid Moustapha, Rania Mohamed El-Gamal, Fathalla Fathalla Belal
Two novel UPLC methods utilizing two different analytical columns and different detection approaches for the simultaneous analysis of velpatasvir and sofosbuvir: application to their co-formulated tablet
BMC Chemistry  13(1), , 2019
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[7]. Safar M. Alqahtani, Mubarak A. Alamri, Alhuamaidi Alabbas, Prawez Alam, Sherif A. Abdel-Gawad, Faiyaz Shakeel, Fatmah A. Alasmary
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How to cite


Abdel-Gawad, S. Eur. J. Chem. 2016, 7(3), 375-379. doi:10.5155/eurjchem.7.3.375-379.1439
Abdel-Gawad, S. Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms. Eur. J. Chem. 2016, 7(3), 375-379. doi:10.5155/eurjchem.7.3.375-379.1439
Abdel-Gawad, S. (2016). Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms. European Journal of Chemistry, 7(3), 375-379. doi:10.5155/eurjchem.7.3.375-379.1439
Abdel-Gawad, Sherif. "Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms." European Journal of Chemistry [Online], 7.3 (2016): 375-379. Web. 16 Jul. 2020
Abdel-Gawad, Sherif. "Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms" European Journal of Chemistry [Online], Volume 7 Number 3 (30 September 2016)

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DOI Link: https://doi.org/10.5155/eurjchem.7.3.375-379.1439

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