Quality by Design (QbD) approach for the development of a rapid UHPLC method for simultaneous determination of aglycone and glycoside forms of isoflavones in dietary supplements,Analytical Methods

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Quality by Design (QbD) approach for the development of a rapid UHPLC method for simultaneous determination of aglycone and glycoside forms of isoflavones in dietary supplements
Analytical Methods ( IF 2.7 ) Pub Date : 2020-03-27 , DOI: 10.1039/c9ay02778e
Kornelija Lasić _{1,

2,

3,

4,

5} , Ana Mornar _{4,

5,

6,

7,

8} , Biljana Nigović _{4,

5,

6,

7,

8}

Affiliation

Systematic development of a UHPLC method with UV detection was performed for simultaneous determination of aglycone (genistein, daidzein, biochanin A and formononetin) and glycoside (genistin, daidzin, sissotrin, ononin) forms of isoflavones. Method development was performed by the QbD approach on three different stationary phases using the DryLab software modelling package. Optimised chromatographic separation was achieved on a Zorbax RRHD Eclipse Plus C18 column with gradient elution in a 2.0 min run time. The resolutions between eight isoflavones were found to be greater than 2.0. The developed method was validated with respect to selectivity, LOD, LOQ, linearity, precision, accuracy, stability and robustness. The proposed method was successfully applied for the analysis of isoflavones present in dietary supplements also containing various other substances. Due to the complex matrices present in the dietary supplements, a 2D-UHPLC-MS method was employed for identification and selectivity confirmation of the developed method. Analysis of investigated dietary supplements revealed deviations between the measured and labelled content of isoflavones as well as high batch to batch variations. The obtained results emphasize the need for quality control of phytoestrogen dietary supplements to provide efficient and safe products.

中文翻译：

设计质量（QbD）方法用于开发快速UHPLC方法，以同时测定膳食补充剂中异黄酮的苷元和糖苷形式

进行了具有紫外检测的UHPLC方法的系统开发，以同时测定异黄酮的苷元（染料木黄酮，黄豆苷元，生物chanin A和formononetin）和糖苷（染料木黄酮，大豆苷，sissotrin，ononin）形式。使用DryLab软件建模软件包通过QbD方法在三个不同的固定相上进行了方法开发。在Zorbax RRHD Eclipse Plus C18色谱柱上以2.0分钟的运行时间进行了梯度洗脱，实现了最佳的色谱分离。发现八个异黄酮之间的分辨率大于2.0。相对于选择性，LOD，LOQ，线性，精度，准确性，稳定性和鲁棒性，对开发的方法进行了验证。所提出的方法已成功地用于分析还含有多种其他物质的膳食补充剂中的异黄酮。由于膳食补充剂中存在复杂的基质，因此采用2D-UHPLC-MS方法对开发的方法进行鉴定和选择性确认。对研究的膳食补充剂的分析显示，异黄酮的含量与标记含量之间存在偏差，并且批次之间的差异很大。获得的结果强调了对植物雌激素膳食补充剂进行质量控制以提供有效和安全产品的必要性。对研究的膳食补充剂的分析显示，异黄酮的含量与标记含量之间存在偏差，并且批次之间的差异很大。获得的结果强调了对植物雌激素膳食补充剂进行质量控制以提供有效和安全产品的必要性。对所研究的膳食补充剂的分析显示，异黄酮的含量与标记含量之间存在偏差，并且批次之间的差异很大。获得的结果强调了对植物雌激素膳食补充剂进行质量控制以提供有效和安全产品的必要性。

更新日期：2020-03-27

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