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PDE5-002
Question
Answer
General
AOAC Method Number:
PDE5-002
Method Title:
Screening Method for Phosphodiesterase Type 5 (PDE5)
Inhibitors in Dietary Ingredients and Supplements
Method Author(s):
Eike Reich, Thi Kieu Tiên Do
Reviewer Name:
Katerina Mastovska
Summary of Method
Samples are extracted with methanol. Extracts are
analyzed by high performance thin layer chromatography
(HPTLC) with UV and MS detection, for detection of
adulteration with sildenafil, vardenafil, tadalafil,
hydroxyacetildenafil, homosildenafil, thiohomosildenafil,
acetildenafil, acetaminotadalafil, propoxyphenyl
hydroxyhomosildenafil, hydroxyhomosildenafil, and
hydroxythiohomosildenafil.
Method Scope / Applicability:
Screening of sildenafil, vardenafil, tadalafil,
hydroxyacetildenafil, homosildenafil, thiohomosildenafil,
acetildenafil, acetaminotadalafil, propoxyphenyl
hydroxyhomosildenafil, hydroxyhomosildenafil, and
hydroxythiohomosildenafil.
General Comments About the
Method:
Tadalafil and its analogs have limited solubility in
methanol, which is used as the extraction/dilution
solvent in the method
Method Clarity
Overall clear description, except for the MS detection.
Which MS spectrometer was used? How were the
eleven target compounds identified/confirmed using
MS?
Pros/Strengths
Relatively simple method for screening of PDE5 inhibitors
but there is not enough information to evaluate the
method performance.
Cons/Weaknesses
Potentially limited scope - reference standards are
necessary for detection in HPTLC.
Estimated detection limit seems to be 20-fold higher
than the AOAC 2014.012 SMPR low concentration of 100