Quality by Design based Development and Validation of UV-spectrometric Method for the Determination of Remdesivir in Bulk and Marketed Formulation

Authors

  • Kashyap Thummar Graduate School of Pharmacy, Gujarat Technological University, Ahmedabad-382424, Gujarat, India https://orcid.org/0000-0002-5603-2330
  • Malay Pandya Graduate School of Pharmacy, Gujarat Technological University, Ahmedabad-382424, Gujarat, India
  • Nisarg Patel Graduate School of Pharmacy, Gujarat Technological University, Ahmedabad-382424, Gujarat, India
  • Foram Rawat Graduate School of Pharmacy, Gujarat Technological University, Ahmedabad-382424, Gujarat, India
  • Sanjay Chauhan Graduate School of Pharmacy, Gujarat Technological University, Ahmedabad-382424, Gujarat, India

Abstract

A simple and rapid UV spectrophotometric method was developed for quantification of remdesivir in bulk and its dosage form which was used in the treatment of COVID 19. Analytical Quality by Design (AQbD) approach was implemented for method development and the relationship between variable input parameters and the method performance characteristics were designed into Ishikawa diagram. The critical parameters were optimized for solvent, wavelength, scan speed and sampling interval, determined by using principal component analysis as well as by observation. The present method was validated according to ICH Q2 (R1) guideline. The method was found excellent linear (r2 ≥ 0.999) at concentration range of 2 -12 μg/mL at maximum wavelength of 245.5 nm. The detection limit and quantitation limit were satisfactorily found to sensitive and precise. The intraday and interday precision were achieved consistent and percentage relative standard deviation (% RSD) were found ≤ 2%. The overall results of forced degradation studies such as acidic, basic, oxidative, thermal and photolytic conditions imply that the developed method could be well implemented as a stability indicating method for the estimation of remdesivir. The result confirmed that the method can be useful for the routine quality control of remdesivir in their pharmaceutical formulations.

Keywords:

Analytical QbD, Covid 19, Remdesivir, UV spectrometry

DOI

https://doi.org/10.25004/IJPSDR.2022.140404

References

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Published

30-07-2022
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How to Cite

“Quality by Design Based Development and Validation of UV-Spectrometric Method for the Determination of Remdesivir in Bulk and Marketed Formulation”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 14, no. 4, July 2022, pp. 385-90, https://doi.org/10.25004/IJPSDR.2022.140404.

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Research Article

How to Cite

“Quality by Design Based Development and Validation of UV-Spectrometric Method for the Determination of Remdesivir in Bulk and Marketed Formulation”. International Journal of Pharmaceutical Sciences and Drug Research, vol. 14, no. 4, July 2022, pp. 385-90, https://doi.org/10.25004/IJPSDR.2022.140404.

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