Stability Indicating HPTLC Method for Analysis of Teriflunomide

DOI:

https://doi.org/10.37285/ijpsn.2020.13.3.6

Authors

  • Mrinalini Damle
  • Pushpraj K Patil

Abstract

Teriflunomide is an immunosuppressive agent that inhibits or prevents activity of immune system. Teriflunomide is not official until to date in IP, USP, and BP. Many studies have reported the HPLC, UPLC, LC/MS methods for estimation of teriflunomide. The current work is intended towards the development of a stability indicating method by high-performance thin layer chromatographic (HPTLC) method coupled with a densitometer for the estimation of Teriflunomide. The chromatographic development was performed on aluminium plates coated with silica gel 60 F254 using toluene: ethyl acetate: glacial acetic acid as the mobile phase. Densitometric scanning was achieved at theabsorbance maxima 294 nm. Teriflunomide was subjected to hydrolysis under different pH conditions, oxidation, thermal and photolytic stress conditions. A well-separated band was observed with Rf value 0.46 ± 0.01. The calibration curve plotted in the concentration range 100-500 ng/band exhibited an excellent linear relationship with the R2 value of 0.997. The method was found to comply with all the validation parameters as per the ICH guidelines Q2 (R1). This stability indicating method ensures short run time compared to other reported analytical methods. This validated method can be used by quality control laboratories for monitoring the stability of teriflunomide. 

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Keywords:

HPTLC, Stability indicating, Teriflunomide, Analysis

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Published

2020-05-31

How to Cite

1.
Damle M, Patil PK. Stability Indicating HPTLC Method for Analysis of Teriflunomide . Scopus Indexed [Internet]. 2020 May 31 [cited 2024 May 18];13(3):4926-31. Available from: https://www.ijpsnonline.com/index.php/ijpsn/article/view/931

Issue

Vol. 13 No. 3 (2020): MAY -JUNE 2020

Section

Research Articles
Crossref
Scopus
Google Scholar
Europe PMC

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