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.

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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
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article

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

Rahul Khemchandani, Gananadhamu Samanthula, Sowmya Chaganti, Dharipally Harini et al.
Rapid Communications in Mass Spectrometry
Analytical Methods in Pharmaceuticals
article

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

Rahul Khemchandani, Gananadhamu Samanthula, Sowmya Chaganti, Dharipally Harini, H. M. Chandra Mouli, Nadeem Shaikh
article en

Abstract

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.

Rapid Communications in Mass SpectrometryVol. 40(3)
National Institute of Pharmaceutical Education and Research - Ahmedabad (IN), National Institute of Pharmaceutical Education and Research (IN)
Openalex Percentile: Top 62%
Analytical Methods in Pharmaceuticals
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