SPDS Set 1 ERP Book

PDE5-003

Question

Answer

General

AOAC Method Number:

PDE5-003

Adaption of the LC-MS Screen for PDE5 Inhibitors to UHPLC-MS

Method Title:

Method Author(s):

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

Reviewer Name:

Phil Koerner

ultra high-performance liquid chromatography with ion trap mass spectrometric detection (UHPLC-MS) for screening of PDE5 inhibitors analogs. screening method for PDE5 inhibitors, analogs, and related compounds. applicable to bulk products, dietary supplements or pharma formulations in solid and liquid forms. 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. 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. MS/MS allows for confirmation of closely eluting PDE5 analogs Analysis time <10 minutes Method dated 2012, since that time other PDE5 analogs have been identified; method does not address availability of reference standards for these PDE5

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Method Clarity

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