Povidone (polyvinylpyrrolidone, PVP) is a commonly used excipient in the formulation of different pharmaceutical dosage forms. It serves as a suspending and dispersing agent, as well as a binding, granulating, and coating agent for tablets.
Nitrites present as impurities in excipients are the primary source of nitrosating agents that can lead to the formation of nitrosamines1. In this process, the rate-limiting factor is usually the trace levels of nitrite, rather than the more abundant secondary amine. This analytical note describes
a selective and sensitive ion chromatography procedure for determining nitrite and nitrate levels in povidone. The method utilizes anion exchange separation coupled with conductivity detection.
Limit of Quantitation (LOQ): 0.2 ÎĽg/g for nitrite and
1.2 ÎĽg/g for nitrate with respect to 25 mg/mL sample
concentration
Validated Range: 0.2 ÎĽg/g - 20 ÎĽg/g for nitrite and 1.2
ÎĽg/g - 40 ÎĽg/g for nitrate with respect to 25 mg/mL sample
concentration.
Precision: %Relative standard deviation (RSD) of nitrite
and nitrate of the 6 recoveries at LOQ levels were less than
20%
Accuracy: %Recovery for nitrite at 0.2 ÎĽg/g, 4 ÎĽg/g, 20
ÎĽg/g and nitrate at 1.2 ÎĽg/g, 8 ÎĽg/g, 40 ÎĽg/g were within
100 ± 30.0%
@mayank.bhanti @Mrunal @SureshP
USP Application Note:
Nitrite and nitrate in povidone_AppNote v03.pdf (1.8 MB)
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