Kota Anil Kumar and Mukthinuthalapati Mathrusri Annapurna*

Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM Deemed to be University, Visakhapatnam, India

*Corresponding Author: Mukthinuthalapati Mathrusri Annapurna, Department of Pharmaceutical Analysis, GITAM School of Pharmacy, GITAM Deemed to be University, Visakhapatnam, India.

Received: March 15, 2023; Published: April 27, 2023

Abstract

Trifluridine is an anti-viral drug. A new stability indicating isocratic LC-MS method has been developed and validated for the quantification of Trifluridine as per ICH guidelines. Thermo scientific-TSQ Quantis with Vanquish HPLC coupled with MS was employed for the present study. Trifluridine and its degradation products were separated using Shimpack C18 (250 mm x 4.6 mm x 5 µm) column using 0.1% acetic acid: methanol as mobile phase at 1.0 ml/min flow rate, 10 μL injection volume and 259 nm detection wavelength. Four major acid degradation products and two alkaline degradation products were identified and characterized by liquid chromatography-APCI mass spectrometry (LC-APCI-MS). The plausible mechanism for the formation of degradation products was identified based on the fragmentation pattern of Trifluridine. The proposed method is simple, precise, accurate, robust and used for the routine analysis of marketed formulations of Trifluridine.

 Keywords: Trifluridine, HPLC, LC-APCI-MS, Forced degradation studies, Validation

References

1. Carmine AA., et al. “Trifluridine: A review of its antiviral activity and therapeutic use in the topical treatment of viral eye infections”. Drugs5 (1989): 329-353.
2. Pavan Langston D and Nelson DJ. “Intraocular penetration of Trifluridine”. American Journal of Ophthalmology6 (1979): 814-818.
3. Sai Pavan Kumar B and Mathrusri Annapurna M. “A validated stability indicating RP-UFLC method for the estimation of Trifluridine-Anti viral drug”. Research Journal of Pharmacy and Technology6 (2022): 2681-2687. 
4. Spandana Yasaswini R., et al. “New stability indicating RP-UFLC method for the determination of Trifluridine-A potent antiviral drug”. Research Journal of Pharmacy and Technology6 (2020): 2881-2885.
5. Sai Gnaneswari A and Mathrusri Annapurna M. “Development and validation of a new stability indicating RP-HPLC method for the determination of Trifluridine”. Acta Scientific Pharmaceutical Sciences12 (2022): 86-93.
6. Mohammad AS., et al. “Method development and validation for the quantitation of Trifluridine in human plasma by using LC-MS/MS technique”. International Journal of Pharm Sciences and Research7 (2020): 3252-3259.
7. Amgad MR. “Improved synthesis of the Anti-SARS-CoV-2 investigational agent (E)-N-(4-cyanobenzylidene)-6-fluoro-3-hydroxypyrazine-2-carboxamide (Cyanorona-20)”. Revista de Chimie4 (2022): 69-75.
8. Amgad MR., et al. “Design, synthesis, and biological evaluation of novel 5-substituted-2-(3,4,5-trihydroxyphenyl)-1,3,4-oxadiazoles as potent antioxidants”. American Journal of Organic Chemistry2 (2016): 54-80.
9. Amgad MR., et al. “Design, synthesis, and biological evaluation of new 5-substituted-1,3,4-thiadiazole-2-thiols as potent antioxidants”. Researcher7 (2018): 21-43.
10. ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization (2005).
11. ICH Stability testing of new drug substances and products Q1A (R2), International Conference on Harmonization (2003).

Citation

Citation: Kota Anil Kumar and Mukthinuthalapati Mathrusri Annapurna. “Stability Indicating LC-APCI-MS Methods for the Quantification of Trifluridine by Tandem Triple Quadrupole Mass Spectrometry". Acta Scientific Pharmaceutical Sciences 7.5 (2023): 39-52.

Copyright

Copyright: © 2023 Kota Anil Kumar and Mukthinuthalapati Mathrusri Annapurna. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.