Determination of Folic Acid in Various Dietary Supplement Dosage Forms by UPLC/PDA: Single-Laboratory Validation, First Action 2024.09.

Lusi A, Mina Fakhary, Jennifer M Solano, Mohamed Koroma
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Abstract

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 as First Action Official Method  SM status.

Objective: The previously published method summarized a single-laboratory validation with parameters of linearity, limit of detection, limit of quantification, repeatability, recovery, specificity, and system suitability. Based on the request from 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% on 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 SMPRSM 2022.002.

不同膳食补充剂剂型中叶酸的UPLC/PDA测定:单实验室验证,第一行动2024.09。
背景:AOAC专家评审小组(ERP)批准了一种定量各种膳食补充剂剂型中叶酸的方法,包括片剂、两片胶囊、粉末饮料、软胶囊和软糖,作为第一行动官方方法SM状态。目的:先前发表的方法总结了单实验室验证参数,包括线性、检出限、定量限、重复性、回收率、特异性和系统适用性。根据ERP的要求,我们按照修改后的程序重新进行了胶粘剂的回收测试。方法:采用超高效液相色谱法(UPLC/PDA)测定各种膳食补充剂剂型中叶酸含量。结果:加峰20%、50%、80%,加峰回收率为94.6 ~ 106.5%。还讨论了对方法的其他调整或澄清和轻微的错别字。结论:在对修订后的方法、报告和结果进行分析和讨论后,ERP采用了该方法,并为达到最终行动状态提供了建议。重点:修订后的方法符合SMPRSM 2022.002的要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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