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 Dec. 24];13(3):4926-31. Available from: https://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

References

Karmankar S and Tajne M (2019). Development of Validated Stability Indicating HPTLC Method for the Estimation of Teriflunomide in Bulk and Tablet Dosage Form. Curr Pharm Anal 15(1): 33-39.
Kimia S, Garrett DA, Dong-Pei Liu, and Rainy PM (2010). A Rapid and Simple High-Performance Liquid Chromatography Assay for the Leflunomide Metabolite, Teriflunomide (A77 1726), in Renal Transplant Recipients. American Journal of Clinical Pathology 133(3): 454-457.
ICH Guideline (2005). Validation of analytical procedures: text and methodology Q2 (R1). International Conference on Harmo-nization, Geneva, Switzerland; pp-1-13.
Mehta B, Pravin P and Yatin G (2017). Development and validation of stability indicating RP-HPLC method for estimation of Teriflunomide in active pharmaceutical ingredient. Pharma Innov 6(9): 440-449.
Nukendra PN, Nadh RV and Srinivasu N (2017). Quality-by-Design Based Development and Validation of a Stability-Indicating UPLC Method for Quantification of Teriflunomide in the Presence of Degradation Products and its Application to Invitro Dissolution. J Liq Chromatogr Relat Technol 40(10): 517-527.
Pandeya S, Asiya M, Singh A, Ahmad FJ, Aqil Mohd, and Talegaonkar S (2018). Development and validation of stability indicating reversed-phase liquid chromatographic method for simultaneous quantification of methotrexate and Teriflunomide in nanoparticles and marketed formulation. Biomed Chromatogr 32(12): 66-72.
Parekh JM, Vaghela RN, Sutariya DK, Sanyal M, Yadav M, and Shrivastav PS (2010). Chromatographic separation and sensitive determination of Teriflunomide, an active metabolite of leflunomide in human plasma by liquid chromatography-tandem mass spectrometry. J Chromatogr B 878(24): 2217-2220.
Patel K, Patel C, Patel M and Patel MM (2017). Development and Validation of Stability Indicating HPLC Method for Estimation of Teriflunomide in API and Pharmaceutical Dosage Form. World J Pharm Pharm Sci 6(12): 780-800.
Prajapat P (2017). Development and validation of stability indicating RP-HPLC method for estimation of teriflunomide in active pharmaceutical ingredient. Pharma Innov. 6.
Rakhila H, Rozek T, Hopkins A, Proudman S, Cleland L, James M, and Michael W (2010). Quantitation of total and free Teriflunomide (A77 1726) in human plasma by LC–MS/MS. J Pharm Biomed Anal 55(2): 320-331.
Rule GS, Rockwood AL and Johnson-Davis KL (2015). LC–MS/MS Method for Determination of Teriflunomide, Over a 40,000-Fold Dynamic Range Using Overlapping Calibrators. Ther Drug Monit 37(4): 472-478.
Shitalaprasad UP, Darji VC, Patel B, and Patel j (2018). Development and Validation of Stability Indicating Assay Method for Estimation of Teriflunomide in Tablet Dosage Form. Indo American J Pharm Sci 5(4): 3209-3219.
Vishwas TS, Gurupadayya BM and Jain R (2019). Novel HPTLC-Densitometric Method for the Estimation of Teriflunomide in Tablet Dosage Form. Int J Pharm Sci 11(6): 80-84.
Yao X, Liu Y, Song L, Jiang J, Xiao F, Liu D, and Hu P (2018). Development of a simple HPLC–MS/MS method to simul-taneously determine Teriflunomide and its metabolite in human plasma and urine: Application to clinical pharmacokinetic study of Teriflunomide sodium and Leflunomide. Biomed Chromatogr 33(3): 22-32.