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PDE5-005

Question

Response

General

AOAC Method Number:

PDE5-005

Method Title:

Single Laboratory Validation Study of a Method for

Screening and

Method Author(s):

Lukas Vaclavik1, John R. Schmitz2, Jean-Francois

Halbardier1 and Katerina Mastovska2*

Reviewer Name:

Teresa Cain

Summary of Method

Liquid chromatography-high resolution mass

spectrometry (LC-HRMS) method for

screening,identification and quantitation of PDE5

inhibitors in dietary ingredients and supplements.

Method Scope / Applicability:

Screening, Identification, Quantitation of adulterants in

dietary supplements

General Comments About the

Method:

Single laboratory validation performed.

Method Clarity

Method is comprehensive and detailed and can be clearly

followed given equivalent instrumentation.

Pros/Strengths

*Appropriate for screening, identification and

quantitation of adulterants.

*Easily adaptable to new analogues.

Cons/Weaknesses

*Fragmentation for the sildenafil class of drugs lacks

structurally significant fragment ions that are typically

seen in literature above m/z 283 or 299.

*Instrumentation utilized is expensive and requires

technically trained operators.

Supporting Data

General Comments

See other fields.

Method Optimization

Since some of the analytes show structurally significant

fragments when there is some parent ion visible, it is

recommended to adjust the fragmentation settings to

less energetic settings, particularly for the sildenafil class