Author(s):
Sanjay D. Sawant, Shital D. Godse
Email(s):
drsdsawant69@gmail.com , shitalgodse.skncop@sinhgad.edu , shitalgodse10@gmail.com
DOI:
10.52711/0974-360X.2025.00176 
Address:
Sanjay D. Sawant1, Shital D. Godse2
1,2Department of Pharmaceutical Chemistry, Sinhgad Technical Education Society’s, Smt. Kashibai Navale College of Pharmacy, Pune, Maharashtra, India.
1,2Department of Pharmaceutical Quality Assurance, Vishwakarma University, Pune-411048, Maharashtra, India.
*Corresponding Author
Published In:
Volume - 18,
Issue - 3,
Year - 2025
ABSTRACT:
The planned study demonstrates the validation of the developed simple, precise, and robust stability-indicating assay method by high-pressure liquid chromatography and the identification and characterization of Brivaracetam (BRV) degradants by High-Performance Liquid Chromatography-Tandem Mass Spectrometry. The drug was exposed to a few stressors i.e. acidic, basic, oxidative, thermal, and UV light to study the stability-indicating behavior of the planned method and observed sufficient degradation in the acidic stressor. All separations were done on Hi-Q SiliC-18 (I250 x 4.6mm, 5µm particle size) by isocratic elution flow at 1ml/min. Detection was set at 210nm. All obtained results indicate that the present method is helpful in the quality control (QC) laboratory to the day-to-day investigation of (BRV) for the assay and degradation products. HPLC method development and validation have been done per the current ICH guidelines. The m/z value obtained in LC-MS analysis of the degradant was used to study further fragmentation patterns, structural elucidation of the degradant, and its pathway.
Cite this article:
Sanjay D. Sawant, Shital D. Godse. LC–ESI-MS Characterization of Degradents of Brivaracetam; Development and Validation of a Stability-Indicating RP-HPLC Method. Research Journal of Pharmacy and Technology. 2025;18(3):1218-3. doi: 10.52711/0974-360X.2025.00176
Cite(Electronic):
Sanjay D. Sawant, Shital D. Godse. LC–ESI-MS Characterization of Degradents of Brivaracetam; Development and Validation of a Stability-Indicating RP-HPLC Method. Research Journal of Pharmacy and Technology. 2025;18(3):1218-3. doi: 10.52711/0974-360X.2025.00176 Available on: https://rjptonline.org/AbstractView.aspx?PID=2025-18-3-37
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