Analysis of counterfeit Cialis® tablets using Raman microscopy and multivariate curve resolution

Area of Science:

• Analytical Chemistry
• Pharmaceutical Sciences
• Spectroscopy

Background:

• Counterfeit medicines pose a significant global health risk.
• Developing robust analytical methods for counterfeit detection is crucial.
• Vibrational spectroscopy with chemometrics is an emerging technique for pharmaceutical analysis.

Purpose of the Study:

• To apply Raman microscopy and multivariate curve resolution (MCR) for the chemical analysis of counterfeit tadalafil tablets.
• To compare the chemical composition and component distribution of counterfeit and genuine tadalafil tablets.
• To evaluate the efficacy of Raman microscopy combined with MCR in detecting counterfeit pharmaceutical products.

Main Methods:

• Raman microscopy was employed to acquire chemical images of tadalafil tablets.
• Multivariate curve resolution (MCR) was utilized to analyze Raman spectra and resolve components.
• Spectra from counterfeit tablets were compared against those from genuine tablets.

Main Results:

• Raman microscopy and MCR successfully identified active pharmaceutical ingredients (API) and excipients in tadalafil tablets.
• Significant differences were observed in excipient identity, API quantity, and component distribution between counterfeit and genuine tablets.
• The analysis revealed both similarities and dissimilarities in the chemical profiles of counterfeit and genuine products.

Conclusions:

• Raman microscopy coupled with MCR is a potent analytical strategy for detecting and characterizing counterfeit tablets.
• This combined technique offers detailed insights into the chemical makeup and spatial distribution of components within pharmaceutical formulations.
• The study highlights the potential of advanced spectroscopic and chemometric methods in combating pharmaceutical counterfeiting.