Guidelines for validating analytical methods for ginsenoside Rg3, Rk1, Rg5 from black ginseng

This study was conducted to establish the manufacturing and quality control of standards for black ginseng and propose a standard analytical method to present marker components different from red ginseng.Changes in the content of ginsenosides Rg3(s), Rk1, and Rg5 were investigated according to the number of steaming and drying processes of black ginseng.In the industrially manufactured black ginseng, the sum of Rg3(s), Rk1, and Rg5 was more than 3 mg/g.In addition, through Ultra-performance liquid chromatography quadrupole time of flight mass spectrometry analysis-based metabolomic analysis, ginsenosides Rg3(s), Rk1, and Rg5 of black ginseng were identified as components differentiated from red ginseng in the results of multivariate statistical analysis and metabolic profiling.The analytical method was validated through HPLC to standardize the marker components.For method validation, the analytical method was tested for specificity, linearity, accuracy, precision, limit of detection, and limit of quantitation, and it was found to be suitable for standardization of marker components.