Identification and Structural Characterization of Degradation Products of Tivozanib Using LC‐Q‐TOF‐MS/MS and NMR: An In Silico Approach for Degradation and Toxicity Prediction
Forced degradation studies were conducted in accordance with ICH Q1A (R2) and Q1B guidelines. Totally, seven DPs were observed in various stress conditions. DP-IV, a structural isomer of TVZ, was detected in basic hydrolytic conditions. The developed RP-HPLC method was validated following the ICH Q2(R1). This study helps in the stability testing and routine quality control analysis during the formulation development of TVZ.
Authors
- Rahul Khemchandani (ORCID: https://orcid.org/0000-0002-3474-7773)
- Gananadhamu Samanthula (ORCID: https://orcid.org/0000-0002-6389-5994)
- Sowmya Chaganti (ORCID: https://orcid.org/0009-0001-6611-1622)
- Dharipally Harini
- H. M. Chandra Mouli
- Nadeem Shaikh
Institutions
- National Institute of Pharmaceutical Education and Research - Ahmedabad (IN)
- National Institute of Pharmaceutical Education and Research (IN)
Publication Details
- Journal
- Rapid Communications in Mass Spectrometry
- Published
- 2025-11-17
- DOI
- https://doi.org/10.1002/rcm.10167
- Primary Topic
- Analytical Methods in Pharmaceuticals
- Type
- article
- Field-Weighted Citation Impact
- 0.00