Method Development and Validation for Nutraceuticals

This article focuses on the analytical approaches that must be considered when performing a method development and validation exercise to ensure that your test method is fit-for-purpose, and meets the regulatory need of your nutraceutical of interest. The ultimate aim is to accurately quantify your nutraceutical of interest whether in final product matrix or as a raw material prior to incorporation into product. Due to the inherent complexity of many of the nutraceutical products that exist on the market, and to the complexity of the nutraceuticals themselves, there is no single analytical approach that can be undertaken. The extraction of the nutraceutical can be performed in a number of ways from simple liquid extraction into water or organic solvent, to more complex distillation procedures. This extraction is prior to final analytical procedures that may be HPLC- or GC-based with fluorescent, UV, mass spectrometric, refractive index, FID or other detection techniques. Additionally, ELISA, enzyme-based kits and chemical assays can be used. These assays are often separate from the type of testing regime that may be necessary to define the physicochemical properties of your product of interest. Therefore, the principles that must be followed to ensure the assay is accurate, precise, reproducible, and fit-for-purpose are outlined.

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