Quantification and structural elucidation of potential impurities in agomelatine active pharmaceutical ingredient.

@article{Liu2013QuantificationAS,
  title={Quantification and structural elucidation of potential impurities in agomelatine active pharmaceutical ingredient.},
  author={Yaxuan Liu and Lei Chen and Yibing Ji},
  journal={Journal of pharmaceutical and biomedical analysis},
  year={2013},
  volume={81-82},
  pages={193-201}
}
Seven impurities in agomelatine drug substance were determined by a newly developed RP-HPLC method. Structures of potential impurities were confirmed by NMR and IR analysis. Efficient chromatographic separation was achieved on Hypersil BDS C18 column (250 mm × 4.6 mm, 5 μm) in gradient mode by using a binary mixture of potassium dihydrogen phosphate (15 mM, pH adjusted to 3.0) and acetonitrile at a flow rate of 1.0 ml/min. A photodiode array detector set at 230 nm was used for detection. Forced… CONTINUE READING