SPDS Set 1 ERP Book

PDE5-003

Question

Answer

General

AOAC Method Number:

PDE5-003

Adaptation of the LC-MS Screen for Phosphodiesterase-5 Inhibitors to UHPLC-MS

Method Title:

Method Author(s):

Valerie M. Toomey, Bethany L. Subel and Cheryl L. Flurer

Reviewer Name:

Fenhong Song

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. 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. 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.

Summary of Method

Method Scope / Applicability:

General Comments About the Method:

Method Clarity

Fair

Highly selective, can be used for the detection of a large number of analytes.

Pros/Strengths