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PDE5-003
Question
Answer
General
AOAC Method Number:
PDE5-003
Method Title:
Adaptation of the LC-MS Screen for Phosphodiesterase-5
Inhibitors to UHPLC-MS
Method Author(s):
Valerie M. Toomey, Bethany L. Subel and Cheryl L. Flurer
Reviewer Name:
Fenhong Song
Summary of Method
The method describes the liquid chromatography-mass
spectrometry (LC-MS) procedure to screen for three
approved phosphodiesterase-type 5 (PDE-5) inhibitors
(sildenafil, tadalafil and vardenafil) and their analogs on
an ion trap platform.
Method Scope / Applicability:
This procedure is applicable to a variety of matrices being
screened for the presence of PDE-5 inhibitors, specifically
sildenafil, tadalafil, vardenafil and avanafil, analogs
thereof, and other related compounds including the
analysis of bulk materials, and dietary supplements or
pharmaceutical formulations in tablet, capsule, or liquid
form. In cases where one or more of the compounds
listed above are detected in a sample, an additional
technique such as LC-UV or FT-IR is recommended for
verification and/or quantitation.
General Comments About the
Method:
This mass spectrometry based method with liquid
chromatograph separation is a very effective and
selective method for the intended purpose. This kind of
method should also be able to be implemented on an
orbitrap platform. There are a few specific aspects of
SMPRs which are not sufficiently addressed:
a. POD at zero, low and high concentration,
b. not all the target compounds are covered in this work,
c. System stability test.
Method Clarity
Fair
Pros/Strengths
Highly selective, can be used for the detection of a large
number of analytes.