Determination of Ginsenoside Content in Panax ginseng C.A. Meyer and Panax quinquefolius L. Root Materials and Finished Products by High-Performance Liquid Chromatography with Ultraviolet Absorbance Detection: Interlaboratory Study

An interlaboratory study was conducted on an HPLC method with UV absorbance detection, previously validated using AOAC single-laboratory validation guidelines, for the determination of the six major ginsenosides (Rg(1), Re, Rb-1, Rc, Rb-2, and Rd) in Panax ginseng C.A. Meyer and Panax quinquefolius L. root materials, extracts, and finished products. Fourteen participating laboratories analyzed five test materials (P. ginseng whole root, P. ginseng powdered extract, P. quinquefolius whole root, P. quinquefolius powdered extract, and P. ginseng powdered extract spiked in a Matrix blank) as blind duplicates, and two test materials (P. ginseng powdered whole root tablet and P. quinquefolius powdered extract hard-filled capsule) as single samples. Due to the variability of the ginsenosides (low level concentration of Rb-2 in P. quinquefolius raw materials and in P. ginseng spiked matrix blanks, and the possibility of incomplete hydrolysis of the finished products during processing), it was deemed more applicable to analyze total ginsenosides rather than individual ones. Outliers were evaluated and omitted using the Cochran's test and single and double Grubbs' tests. The reproducibility RSD (RSDR) for the blind duplicate samples ranged from 4.38 to 5.39%, with reproducibility Horwitz Ratio (HorRat(R)) values ranging from 1.5 to 1.9. For the single replicate samples, the data sets were evaluated solely by their repeatability HorRat (HorRat(r)), which were 2.9 and 3.5 for the capsule and tablet samples, respectively. Based on these results, the method is recommended for AOAC Official First Action for the determination of total ginsenosides in P. ginseng and P. quinquefolius root materials and powdered extracts.