Validation of RP-HPLC Method for Determination of Sofosbuvir in Bulk and Pharmaceutical Dosage Forms

DOI:

https://doi.org/10.37285/ijpsn.2020.13.2.4

Authors

  • Abrar Ahmed
  • Tayyaba Mahtab
  • Sumaiyya Saleem
  • Srinivas Akula
  • Mohammed Dilawar Khan

Abstract

A simple, accurate, economic and precise RP-HPLC method was developed to determine sofosbuvir in bulk and tablet dosage form and validated following the ICH guidelines for various parameters such as precision, linearity, accuracy, specificity and robustness. Sofosbuvir is used to treat viral diseases such as Hepatitis-C.  The detection was carried out Agilent Eclipse® XDB-C18, 5µm 4.6×250 mm column using gradient composition of 0.03M KH2PO4 in 1000 ml of water adjusted to a pH of 2.5 with dilute orthphosphoric acid. A flow rate of 1ml/minute with detection wavelength at 260 nm was used. Retention time was found to be 3.166 and the linearity of this method was observed over the range of 40-240 µg/ml. The linear regression equation from the linearity study was Y = 32036x + 75288. Limit of detection (LOD) and limit of quantitation (LOQ) was 0.02 µg/ml and 0.06 µg/ml respectively. The assay percent of sofosbuvir was found to be 109.6% whereas percentage recovery of sofosbuvir for average of three concentrations was 96.51%. This confirms the high accuracy of the assay method. In conclusion, the validated method can be used to analyze the marketed formulations. 

 

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Keywords:

Sofosbuvir, HPLC, Accuracy, ICH guidelines

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Published

2020-03-31

How to Cite

1.
Ahmed A, Mahtab T, Saleem S, Akula S, Khan MD. Validation of RP-HPLC Method for Determination of Sofosbuvir in Bulk and Pharmaceutical Dosage Forms. Scopus Indexed [Internet]. 2020 Mar. 31 [cited 2024 Sep. 19];13(2):4826-30. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/259

Issue

Vol. 13 No. 2 (2020): March-April 2020

Section

Research Articles
Crossref
Scopus
Google Scholar
Europe PMC

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