European Journal of Chemistry 2016, 7(3), 375-379. doi:10.5155/eurjchem.7.3.375-379.1439

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

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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Citations

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[1]. Dalia W. Zidan, Wafaa S. Hassan, Manal S. ElMasry, Abdalla A. Shalaby
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[2]. Rania M. El-Gamal, Sherif A. Abdel-Gawad, Fathalla F. Belal, Moustapha E. Moustapha
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[3]. Sherif Abdel-Naby Abdel-Gawad
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[4]. Aya A Youssef, N Magdy, Lobna A Hussein, A M El-Kosasy
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[5]. Roshdy E. Saraya, Magda Elhenawee, Hanaa Saleh
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[6]. Moustapha Eid Moustapha, Rania Mohamed El-Gamal, Fathalla Fathalla Belal
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[7]. Maha Osama El-Kayal, Maha Nasr Sayed, Nahed Dawood Mortada, Seham Elkheshen
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[8]. Mansuri Reema, Patel Dhara, Patel Khushboo, Meshram Dhananjay
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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. 23 Oct. 2019
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)

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

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