Evaluation of nystatin stability using tristimulus colorimetry

Area of Science:

• Pharmaceutical Sciences
• Analytical Chemistry

Background:

• Nystatin is an antifungal medication.
• Assessing drug stability is crucial for efficacy and safety.
• Color change can indicate degradation.

Purpose of the Study:

• To investigate the relationship between nystatin color change and microbiological potency loss during accelerated stability studies.
• To evaluate the utility of tristimulus spectrophotometry for monitoring nystatin degradation.

Main Methods:

• Utilized a tristimulus reflectance spectrophotometer to measure color changes in nystatin.
• Applied the Kubelka-Munk equation to remission function calculations.
• Correlated color changes with microbiological potency loss during thermal degradation.

Main Results:

• A direct relationship was observed between nystatin's color change and its loss of microbiological potency.
• The remission function, calculated using tristimulus values and the Kubelka-Munk equation, showed a linear response over time.
• The technique was successfully applied to both bulk nystatin raw materials and formulated products.

Conclusions:

• Tristimulus spectrophotometry is a viable method for monitoring nystatin stability.
• Color change serves as a reliable indicator of nystatin degradation and potency loss.
• This technique offers a non-destructive way to assess the quality of nystatin products.