Skip to content
Research Article Open access CC BY 4.0

Uv Spectrophotometric Methods for Determination of Sofosbuvir in Pure Form and Pharmaceutical Dosage Forms in Presence of Its Alkaline Degradate

Zeinab Adel Nasr, Noha S. Said, Sawsan A. Abdel-Razeq

Asian Journal of Applied Chemistry Research · pp. 12–25 · Published 22 Apr 2020

10.9734/ajacr/2020/v5i230129

Abstract

Aims: Two spectrophotometric methods were developed and validated for the determination of sofosbuvir in presence of its alkaline degradate. Study Design: Ratio difference and ratio derivative methods were assisted for determination of sofosbuvir in presence of its alkaline degradate, laboratory-prepared mixtures and in tablet dosage forms. Place and Duration of Study: Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy (Girls), Al - Azhar University, between December 2019 and January 2020. Methodology: Two analytical methods were achieved and validated for the quantitative determination of Sofosbuvir in presence of its alkaline degradate. The first method was ratio difference (RD) method, where the UV absorption spectra of different concentrations of sofosbuvir were divided by the spectrum of a certain concentration (15 µg mL-1) as a devisor of its alkaline degradate to get the ratio difference spectra. Afterwards, the peak amplitudes difference between 253.7 and 243.5 nm were measured. The second method was the ratio derivative (1DR) method, where the first derivative of the ratio spectra (1DR) was obtained and its amplitude was measured at 247 and 268 nm. Good linearity was obtained over the concentration range of 3-15 µg mL-1 for the proposed methods. The proposed procedures were adopted for the selective determination of intact Sofosbuvir in presence of up to 80% of its degradation product. Sofosbuvir was exposed to different conditions as alkaline, acidic and oxidative degradation. Results: The proposed methods were developed and validated with good linearity range of 3-15 µg mL-1 for both methods, and also with good accuracy and precision. And the obtained results were statistically compared to those obtained by the reported method. Conclusion: Sofosbuvir was successfully determined by the proposed ratio difference and ratio derivative methods in bulk powder, laboratory prepared mixtures and tablet dosage form with good accuracy and precision. The methods were validated according to ICH guidelines. The results obtained were compared with those of the reported method and were found to be in good agreement.

Sofosubvir ratio difference first-derivative of ratio spectra spectrophotometry.

References (15)

  1. 1 Vogel's textbook of quantitative chemical analysis
  2. 2 Development of a sensitive UPLC-ESI-MS/MS method for quantification of sofosbuvir and its metabolite, GS-331007, in human plasma: Application to a bioequivalence study [DOI]
  3. 3 Simultaneous determination of ledipasvir, sofosbuvir and its metabolite in rat plasma by UPLC–MS/MS and its application to a pharmacokinetic study [DOI]
  4. 4 Stability-Indicating Method and LC–MS-MS Characterization of Forced Degradation Products of Sofosbuvir [DOI]
  5. 5 Spectrophotometric assessment of the brand new antiviral combination: Sofosbuvir and velpatasvir in their pure forms and pharmaceutical formulation [DOI]
  6. 6 BIOANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF SOFOSBUVIR FROM HUMAN PLASMA [DOI]
  7. 7 Validation and Application of a Liquid Chromatography-Tandem Mass Spectrometry Method To Determine the Concentrations of Sofosbuvir Anabolites in Cells [DOI]
  8. 8 Simple chromatographic and spectrophotometric determination of sofosbuvir in pure and tablet forms [DOI]
  9. 9 Validated RP-HPLC Method for Simultaneous Determination of Ribavirin, Sofosbuvir and Daclatasvir in Human Plasma: A Treatment Protocol Administered to HCV Patients in Egypt [DOI]
  10. 10 DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF SOFOSBUVIR BY FORCED DEGRADATION STUDIES [DOI]
  11. 11 Development and validation of a versatile HPLC-DAD method for simultaneous determination of the antiviral drugs daclatasvir, ledipasvir, sofosbuvir and ribavirin in presence of seven potential impurities. Application to assay of dosage forms and dissolution studies [DOI]
  12. 12 Validated Stability – Indicating Methods for Determination of Sofosbuvir by UPLC and HPTLC in Pure Form and Tablet Dosage Forms [DOI]
  13. 13 Estimation of Sofosbuvir with Validated Ultra High Performance Liquid Chromatographic (UHPLC) Method in its bulk and Formulations
  14. 14 STABILITY-INDICATING HPLC AND UV SPECTROPHOTOMETRIC DETERMINATION OF SOFOSBUVIR IN PURE FORM AND TABLETS [DOI]
  15. 15 Journal of pharmaceutical and biomedical analysis [DOI]

Cited by 3

A Stability Indicating Reverse Phase High Performance Liquid Chromatography Method for Related Substances of Sofosbuvir in Tablet Dosage Form

BINAL N. PATEL, Hitesh J. Vekaria · International Journal of Pharmaceutical Sciences and Drug Research · 2023

SPECTROPHOTOMETRIC METHODS FOR DETERMINATION OF SOFOSBUVIR AND DACLATASVIR IN PURE AND DOSAGE FORMS

Mоnir Z. Sааd, Atef Amer, Khaled Mansour Elgendy · International Journal of Applied Pharmaceutics · 2021

Spectrofluorimetric Quantification of Sofosbuvir Using MBTH Reagent and Ferric Chloride in Bulk and Tablet Dosage Form

Soujanya Chaganti, Priyanka Chitukula, Swathi Naraparaju · International Journal of Pharmaceutical Sciences Review and Research · 2023

Related research

Article metrics

Real usage data collected on this platform.

8

Page views

0

PDF downloads

1

Outbound clicks

3

Citations

Views over time

Views by country

Approximate, from request IP at view time — not citizenship or institution. Countries with fewer than 5 views are grouped as "Other".

Traffic sources

Referring site, by host.

Views and downloads exclude known bots/crawlers. Citations combines this platform's own DOI-resolved index with each external source's own reported total — see Cited by above for individually listed citing works. Last refreshed 0 seconds ago.