Identification and characterization of degradation products of Nateglinide

Nateglinide (NTG) was evaluated under a variety of ICH-recommended forced degradation settings and found to be degraded under acid and alkali hydrolysis but stable under other forced degradation conditions. Under acid hydrolytic conditions, three degradation impurities (I-III) were produced. All three contaminants were separated using a C-18 column with ammonium acetate buffer (20 mM), methanol, and acetonitrile as mobile phases provided in isocratic mode, and characterisation was done utilising +ESI-MSn and LC-MS-QTOF investigations. All three degrading impurities (I-III) were discovered to be novel. The most likely pathways of deterioration were presented and debated.