Acta Scientific Pharmaceutical Sciences (ASPS)(ISSN: 2581-5423)

Research Article Volume 6 Issue 12

Development and Validation of a New Stability Indicating RP-HPLC Method for the Determination of Trifluridine

Sai Gnaneswari Aluri and Mukthinuthalapati Mathrusri Annapurna*

Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, India

*Corresponding Author: Mukthinuthalapati Mathrusri Annapurna, Department of Pharmaceutical Analysis, GITAM School of Pharmacy, Gandhi Institute of Technology and Management (Deemed to be University), Visakhapatnam, India.

Received: October 21, 2022; Published: November 30, 2022

Abstract

Trifluridine is an anti-viral drug used for treatment and prevention of vaccinia viral infections on eye. Trifluridine is used to treat herpes viral infections as well as the inflammation of eye. The present study describes the development and validation of RP-HPLC method for the estimation of Trifluridine in ophthalmic preparations using Shimadzu Model CBM-20A/20 Alite HPLC system consisting of PDA (Photo diode array) detector. A mixture of Formic acid: Methanol (45:55, v/v) was used as mobile phase with flow rate 1.0 mL/min. The proposed method was developed using C18 Agilent column (250 mm × 4.60 mm, 5 μm) on an isocratic mode at room temperature with UV detection at 259 nm. Trifluridine obeys Beer-Lambert’s law over the concentration range 0.5-120 µg/mL with linear regression equation y = 40447x - 793.8 (R² = 0.9997). The method was validated as per ICH guidelines and showed excellent precision, robustness, accuracy, linearity, specificity and the system suitability parameters were within the acceptable criteria. The limit of detection (LOD) and limit of quantification (LOQ) values were found to be 0.1541 µg/mL and 0.4691 µg/mL respectively. Forced degradation studies were performed by exposing Trifluridine to stress conditions such as acidic hydrolysis, alkaline hydrolysis, thermal degradation and oxidation and the degradant products were separated successfully from the API.

Keywords: Trifluridine; Limit of Quantification (LOQ); Limit of Detection (LOD)

References

  1. De Clercq E. “Antiviral drugs in current clinical use”. Journal of Clinical Virology2 (2004): 115-133.
  2. 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.
  3. Pavan Langston D and Nelson DJ. “Intraocular penetration of Trifluridine”. American Journal of Ophthalmology 6 (1979): 814-818.
  4. Chen X., et al. “Therapeutic target database”. Nucleic Acids Research1 (2002): 412-415.
  5. Valli Kumari RV and G Vardhani. “RP HPLC method development and validation for simultaneous determination of Trifluridine and Tipiracil in pure and tablet dosage form”. International Journal of Pharmacy and Analytical Research3 (2019): 377-386.
  6. Hazra BB., et al. “Analytical method development and validation for simultaneous estimation of Trifluridine and Tipiracil in pure and pharmaceutical dosage form”. Innovative International Journal of Medical and Pharmaceutical Sciences1 (2018): 55-58.
  7. Sahu SK and Akula G. “Development and validation of a RP-HPLC-PDA method for simultaneous determination of Trifluridine and Tipiracil in pure and pharmaceutical dosage form”. International Journal of Novel Trends in Pharmaceutical Sciences5 (2017): 145-151.
  8. Mastanamma SK., et al. “Development and Validation of Stability indicating RP-HPLC method for the simultaneous estimation of Trifluridine and Tipiracilin bulk and their combined dosage form”. International Journal of ChemTech Research4 (2019): 117-126.
  9. Kusuma J., et al. “An effective and sensitive stability indicating chromatographic approach based on RP-HPLC for trifluridine and tipiracil in bulk and pharmaceutical dosage form”. International Journal of Research in Pharmacy and Chemistry1 (2017): 63-70.
  10. Rizwan MSH., et al. “Analytical method development and validation for the simultaneous determination of Tipiracil and Trifluridine in bulk and capsule dosage form by RP-HPLC method”. International Journal of Innovative Pharmaceutical Sciences and Research9 (2017): 32-42.
  11. Swapna G., et al. “Development and validation of stability indicating RP-HPLC method for the simultaneous estimation of combination drugs Trifluridine and Tipiracil in bulk and pharmaceutical dosage forms”. International Journal of Research in Applied, Natural and Social Sciences2 (2017): 93-104.
  12. Prathap B., et al. “Method development and validation for the simultaneous estimation of Trifluridine and Tipiracil in tablet dosage form by RP-HPLC method”. Journal of Global Trends in Pharmaceutical Sciences4 (2017): 4514-4521.
  13. Phani RS Ch., et al. “New bio analytical method development and validation for the simultaneous estimation of Trifluridine and Tipiracil in spiked human plasma”. Research Journal of Pharmacy and Technology 12 (2017): 4264-4268.
  14. Asha Eluru and K Surendra Babu. “A New Selective Separation method development and Validation of Trifluridine and Tipiracil and its degradants were characterized by LC-MS/MS/QTOF”. Journal of Pharmaceutical Sciences and Research1 (2020): 199-205.
  15. Spandana Yasaswini R., et al. “New spectrophotometric methods for the determination of Trifluridine”. Research Journal of Pharmacy and Technology 2 (2020): 939-944.
  16. 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 Pharmaceutical Sciences and Research 7 (2020): 3252-3259.
  17. 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.
  18. ICH Validation of analytical procedures: Text and methodology Q2 (R1), International Conference on Harmonization (2005).
  19. ICH Stability Testing of New Drug Substances and Products Q1A (R2), International Conference on Harmonization (2003).

Citation

Citation: Sai Gnaneswari Aluri and Mukthinuthalapati Mathrusri Annapurna. “Development and Validation of a New Stability Indicating RP-HPLC Method for the Determination of Trifluridine". Acta Scientific Pharmaceutical Sciences 6.12 (2022): 86-93.

Copyright

Copyright: © 2022 Sai Gnaneswari Aluri 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.




Metrics

Acceptance rate32%
Acceptance to publication20-30 days

Indexed In




News and Events


Contact US