Identification, Isolation, and Characterization of a New Degradation Impurity in Nafcillin Sodium.

A new degradant of Nafcillin Sodium was found at a level of 1.8% w/w during the gradient reversed-phase HPLC analysis in stability storage samples. This impurity was identified by LC-MS and was characterized by (1)H-NMR, (13)C-NMR, LC/MS/MS, elemental analysis, and IR techniques.

Gradient RP-HPLC method for the determination of potential impurities in atazanavir sulfate.

This paper proposes a simple and selective RP-HPLC method for the determination of process impurities and degradation products (degradants) of atazanavir sulfate (ATV) drug substance. Chromatographic separation was achieved on Ascentis(®) Express C8, (150mm×4.6mm, 2.