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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.