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Background The objective of the work carried out was to assess the toxicity of the degradation products (DPs) for the drug felbamate. Stress studies were performed in the condition specified in the international council of harmonization (ICH) guideline Q1A (R2). Results The drug degraded under the alkaline stress conditions to generate two degradation products (DPs). They were separated on a Phenomenex C8 column (250 mm × 4.6 mm, 5 µm); mobile phase composition was 10 mM ammonium formate (pH adjusted to 3.7 with formic acid) and acetonitrile (80:20, v/v); flow rate and wavelength for recording absorbance were 1.0 ml/min and 206 nm, respectively. The structures of the degradation products were characterized by LC–MS/MS analysis. Conclusion The drug was prone to hydrolysis in the presence of alkali. It was found to be stable under other stress conditions, viz., acidic, neutral, thermal, photolytic and oxidative. The structures of the impurities were characterized by LC–MS/MS. The drug and the DPs were screened through ADME and toxicity prediction software’s like pkCSM, Toxtree and OSIRIS property explorer. Felbamate was flagged for possible hepatotoxicity. |
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