Abstract
In the present study, we report the results of our investigation of the oxidative forced degradation of glutathione in its nutraceutical formulations by two validated analytical methods. The first is based on the reaction of glutathione with o-phthalaldehyde through an automated zone fluidics flow platform and fluorimetric detection (λex/λem = 340/425 nm). The second is based on the separation of glutathione and its oxidation product by a green reversed-phase HPLC method coupled to direct UV detection, at 210 nm. A solution of 3% w/v H2O2 provided fast oxidation of more than 95% of glutathione to yield oxidized glutathione in a time period of 180 min. The mechanism of the oxidation was proved to follow pseudo-first order kinetics. The k, t90 and t1/2 values were calculated.
Highlights
Forced degradation includes a group of actions that involves the intentional subjecting of drug products and active ingredients at conditions more severe than accelerated stability ones
The objectives of the present report was to subject glutathione (GSH)-containing nutraceuticals in oxidation forced degradation studies, including the investigation of the oxidation kinetics by two newly developed and validated analytical methods: (i) an automated flow method that is based on the reaction of GSH with (OPA) under zone fluidics (ZF) conditions [8]; and (ii) a simple and green
The zone fluidics (ZF) instrumentation consisted of a peristaltic pump (Minipuls3, Gilson, Middleton, WI, USA), a micro-electrically actuated 10-port valve (Valco, Ontario, Canada) and a flow-through spectrofluorimetric detector (RF-551, Shimadzu, Kyoto, Japan)
Summary
Forced degradation includes a group of actions that involves the intentional subjecting of drug products and active ingredients at conditions more severe than accelerated stability ones (hydrolysis, photolysis, thermal and oxidation). One of the main chemical reactions that affects the stability of a drug is oxidation, which involves the removal of electrons from a molecule (or the addition of oxygen). Such reactions can typically be initiated by light, heat or certain trace metals. Despite the fact that oxidation is a rather common pathway for drug decomposition, it has not been investigated in the same extent compared to, e.g., hydrolysis, since specific actions can reduce its effect to acceptable levels (e.g., storage in the absence of light and oxygen, use of antioxidants in the formulation, etc.) [3]
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