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PDE5-003
Question
Answer
General
AOAC Method Number:
PDE5-003
Method Title:
Adaption of the LC-MS Screen for PDE5 Inhibitors to
UHPLC-MS
Method Author(s):
Valerie M. Toomey, Bethany L. Subel, and Cheryl L. Flurer
Reviewer Name:
Phil Koerner
Summary of Method
ultra high-performance liquid chromatography with ion
trap mass spectrometric detection (UHPLC-MS) for
screening of PDE5 inhibitors analogs.
Method Scope / Applicability:
screening method for PDE5 inhibitors, analogs, and
related compounds.
applicable to bulk products, dietary supplements or
pharma formulations in solid and liquid forms.
General Comments About the
Method:
addresses basic fundamentals for PDE5 screening
method, but no single lab validation data and no POD
data included.
Appears to be a solid screening method that should be
adaptable to include additional PDE5 analogs - this must
be demonstrated.
This LC/MS/MS method used in conjunction with other
techniques (NMR & accurate mass determination) would
be very useful for identification of related PDE5 analogs.
Method Clarity
Detailed mass transitions for range of PDE5 analogs
provided. Very specific MS parameters detailed for MS
used by authors. Specific MS instrument parameters will
vary with system so will need to be determined and
optimized.
Pros/Strengths
MS/MS allows for confirmation of closely eluting PDE5
analogs
Analysis time <10 minutes
Cons/Weaknesses
Method dated 2012, since that time other PDE5 analogs
have been identified; method does not address
availability of reference standards for these PDE5