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Profiling counterfeit Cialis, Viagra and analogs by UPLC-MS
Rafael S Ortiz1, Kristiane de Cássia Mariotti, Maribete H Holzschuh
1Rio Grande do Sul Technical and Scientifical Division, Brazilian Federal Police, 90160-093 Porto Alegre, RS, Brazil. rafaelortiz.rso@dpf.gov.br
Forensic Science International
|May 21, 2013
Summary
This study analyzed erectile dysfunction tablets, distinguishing authentic from counterfeit versions using UPLC-MS. Counterfeit drugs often contained undeclared active pharmaceutical ingredients (APIs) or higher concentrations than legitimate products.
Area of Science:
- Analytical Chemistry
- Forensic Chemistry
- Pharmaceutical Analysis
Background:
- Erectile dysfunction medications like sildenafil citrate (Viagra) and tadalafil (Cialis) are widely used.
- The prevalence of counterfeit pharmaceuticals poses significant health risks due to unknown ingredients and dosages.
- Accurate methods are needed to differentiate authentic drugs from counterfeit versions.
Purpose of the Study:
- To develop and validate a rapid analytical method for identifying and quantifying sildenafil citrate and tadalafil in erectile dysfunction tablets.
- To distinguish between authentic and counterfeit erectile dysfunction medications.
- To investigate the chemical profiles and active pharmaceutical ingredient (API) content of commercial and counterfeit samples.
Main Methods:
- Ultra-performance liquid chromatography coupled with diode array detection and mass spectrometry (UPLC-DAD-MS) was employed.
- Methanol extracts of 43 commercial and 65 counterfeit erectile dysfunction tablets were analyzed.
- A validated method allowed for the simultaneous determination of sildenafil citrate (SLD) and tadalafil (TAD).
- Chemometric methods were used to group samples based on API content.
Main Results:
- The UPLC-MS method provided high resolution and rapid analysis (under 1.5 minutes) for distinguishing authentic from counterfeit tablets.
- Most analyzed samples, particularly counterfeit ones, contained undeclared active pharmaceutical ingredients (APIs) or significantly higher concentrations of sildenafil citrate and tadalafil than specified.
- Chemometric analysis successfully grouped the samples into five distinct clusters based on API composition.
Conclusions:
- The developed UPLC-MS method is a reliable and efficient tool for the quality control and authentication of erectile dysfunction medications.
- Counterfeit erectile dysfunction tablets frequently deviate from labeled content, presenting potential risks to consumers.
- This analytical approach aids in combating pharmaceutical fraud and ensuring patient safety.
