Noxythiolin--high-performance liquid chromatographic assay and stability.

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences

Background:

• Noxythiolin stability is crucial for its efficacy and safety.
• Accurate shelf-life determination requires reliable analytical methods.

Purpose of the Study:

• To develop a stability-indicating assay for noxythiolin.
• To apply the assay for determining the shelf-life of noxythiolin in various forms.
• To evaluate kinetic models for noxythiolin degradation.

Main Methods:

• Development of a rapid, stability-indicating high-performance liquid chromatographic (HPLC) assay.
• Application of the HPLC assay to solid and solution formulations of noxythiolin.
• Evaluation of kinetic models (A B + C, A B, first-order) to describe degradation profiles.

Main Results:

• A validated HPLC method for noxythiolin stability assessment was established.
• The assay successfully determined the shelf-life of noxythiolin in solid and solution states.
• Kinetic modeling provided insights into degradation pathways, differentiating concentrated and dilute solutions.

Conclusions:

• The developed HPLC assay is suitable for noxythiolin shelf-life determination.
• Kinetic models effectively describe noxythiolin degradation, with variations based on concentration.
• This work contributes to ensuring the quality and stability of noxythiolin pharmaceutical products.