A Single-Laboratory Validation of a UPLC Method for Determination of Folic Acid in Various Dietary Supplement Dosage Forms.

Journal of AOAC International Pub Date : 2024-03-01 DOI:10.1093/jaoacint/qsad128

Lusi A, Mina Fakhary, Niloufar Rahimi Gaeini, Jennifer M Solano, Mohamed Koroma

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Abstract

Background: Folic acid is an essential nutrient necessary for the synthesis of nucleic acids (DNA and RNA) and certain amino acids. There are no scientifically validated analytical methods for folic acid applicable to all dosage forms.

Objective: A single-laboratory method was validated for the determination of folic acid content in various dietary supplement dosage forms. This method used ultra-performance liquid chromatography/diode-array detector (UPLC/PDA) to determine the folic acid content in dietary supplements in the form of tablets, two-piece capsules, powder drinks, softgels, and gummies.

Method: The ultra-performance liquid chromatography/diode-array detector method was evaluated for linearity, limit of detection (LOD), limit of quantification (LOQ), repeatability, recovery, specificity, and system suitability.

Results: Linearity of the folic acid standard was shown to be linear in the range of 0.45 µg/mL to 7.37 µg/mL. LOD and LOQ of folic acid were 0.089 and 0.268 µg/mL, respectively. The repeatability of nine samples from five matrixes resulted in 1.15-4.82% relative standard deviation (RSD). Five samples with five different matrixes spiked with 25, 50, and 100% of working standard concentration and had a recovery range of 95.48-104.72%. The chromatograms and spectra of the blank, standard, and sample solutions showed that the method was free of interference for folic acid. The system suitability results of different matrixes showed that the UPLC/PDA system is suitable for folic acid analysis. All the AOAC INTERNATIONAL SMPR® 2022.002 requirements were fulfilled.

Conclusions: The ultra-performance liquid chromatography/diode-array detector method compares favorably with the requirements of AOAC SMPR 2022.002.

Highlights: The UPLC/PDA method is fast and suitable for all dietary supplement matrixes studied. The method meets the requirements of SMPR 2022.002.

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不同膳食补充剂剂型中叶酸含量的UPLC测定方法的单实验室验证。

背景:叶酸是合成核酸(DNA和RNA)和某些氨基酸所必需的营养素。没有科学验证的叶酸分析方法适用于所有剂型。目的:建立单实验室测定各种膳食补充剂剂型中叶酸含量的方法。本方法采用超高效液相色谱/二极管阵列检测器(UPLC/PDA)对片剂、片式胶囊、粉状饮料、软胶囊、软糖等膳食补充剂中叶酸的含量进行测定。方法:对超高效液相色谱/二极管阵列检测器方法的线性度、检出限(LOD)、定量限(LOQ)、重复性、回收率、专属性和系统适用性进行评价。结果:叶酸标准品在0.45µg/mL ~ 7.37µg/mL范围内呈线性关系。叶酸的定量限和定量限分别为0.089µg/mL和0.268µg/mL。5种基质中9个样品的重复性为1.15 ~ 4.82%。5种不同基质的5个样品，加标浓度分别为工作标准浓度的25%、50%和100%，加标回收率为95.48 ~ 104.72%。空白溶液、标准溶液和样品溶液的色谱和光谱分析表明，该方法对叶酸无干扰。不同基质的系统适用性结果表明，UPLC/PDA系统适用于叶酸分析。AOAC SMPR 2022.002的所有要求都得到了满足。结论:超高效液相色谱/二极管阵列检测法符合AOAC SMPR 2022.002的要求。UPLC/PDA方法快速，适用于所研究的所有膳食补充剂基质。该方法满足SMPR 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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Journal of AOAC International

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