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
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
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: © 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.