SPDS Set 1 ERP Book

PDE5-005

Question

Response

General

AOAC Method Number:

PDE5-005

Single Laboratory Validation Study of a Method for Screening and Lukas Vaclavik1, John R. Schmitz2, Jean-Francois Halbardier1 and Katerina Mastovska2*

Method Title:

Method Author(s):

Reviewer Name:

Teresa Cain

Liquid chromatography-high resolution mass spectrometry (LC-HRMS) method for screening,identification and quantitation of PDE5 inhibitors in dietary ingredients and supplements. Screening, Identification, Quantitation of adulterants in dietary supplements

Summary of Method

Method Scope / Applicability:

General Comments About the Method:

Single laboratory validation performed.

Method is comprehensive and detailed and can be clearly followed given equivalent instrumentation. *Appropriate for screening, identification and quantitation of adulterants. *Easily adaptable to new analogues. *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

Method Clarity

Pros/Strengths

Cons/Weaknesses

General Comments

See other fields.

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

Method Optimization