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Published on: June 30, 2020
Determination of Folic Acid in Various Dietary Supplement Dosage Forms by UPLC/PDA: Single-Laboratory Validation,
Lusi A1, Mina Fakhary1, Jennifer M Solano1
1Pharmavite LLC, R&D Department, 28310 Livingston Ave, Valencia, CA 91355, USA.
Background:
The AOAC Expert Review Panel (ERP) approved a method for the quantification of folic acid in various dietary supplement dosage forms containing tablets, 2-piece capsules, powder drinks, softgels, and gummies with First Action Official MethodSM status.
Objective:
The previously published method summarized a single-laboratory validation with parameters of linearity, LOD, LOQ, repeatability, recovery, specificity, and system suitability. Based on the request from the ERP, the recovery test for the gummies has been reperformed with a revised procedure.
Methods:
Determination of Folic Acid in Various Dietary Supplement Dosage Forms UPLC/PDA.
Results:
The recovery range of 94.6-106.5% was achieved by spiking 20, 50, and 80% in the gummy samples. Other adjustments or clarification of the method and minor typos were also addressed.
Conclusion:
After the revised method, report, and results were analyzed and discussed, the ERP adopted the method and provided recommendations for achieving Final Action status.
Highlights:
The revised method meets the requirements of Standard Method Performance Requirement (SMPR®) 2022.002.
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