NIR hyperspectral imaging to evaluate degradation in captopril commercial tablets

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences
• Spectroscopy

Background:

• Pharmaceutical quality control is crucial for drug effectiveness, safety, and preventing degradation.
• Monitoring drug degradation throughout shelf life is essential for maintaining product quality.

Purpose of the Study:

• To evaluate the degradation of captopril into captopril disulfide in tablets using near infrared hyperspectral images (HSI-NIR).
• To develop a model for estimating tablet manufacturing dates based on degradation patterns observed in HSI-NIR data.

Main Methods:

• Near infrared hyperspectral images (HSI-NIR) of tablets with varying expiration dates were acquired.
• Multivariate curve resolution (MCR) models were used to generate concentration distribution maps (CDMs) from HSI-NIR data.
• Multivariate image techniques were applied to CDMs to extract features for model building.

Main Results:

• The developed model successfully estimated tablet manufacture dates with a prediction error of 120 days.
• The method demonstrated the ability to assess if a sample's degradation pattern aligns with its manufacturing date.
• HSI-NIR provided insights into the active pharmaceutical ingredient's (API) behavior during the product's shelf life.

Conclusions:

• HSI-NIR combined with MCR and multivariate image analysis is a powerful tool for pharmaceutical quality control.
• This approach can detect abnormal degradation patterns and ensure drug product integrity.
• The findings support the application of HSI-NIR in Quality by Design (QbD) for pharmaceutical development.