Determination of ginsenoside content in Asian and North American ginseng raw materials and finished products by high-performance liquid chromatography: single-laboratory validation.

A single-laboratory validation study was conducted for the quantification of Rg1, Re, Rb1, Rc, Rb2, and Rd in Asian ginseng (Panax ginseng C.A. Meyer) and North American ginseng (Panax quinquefolius L.) raw materials and finished products by RP-HPLC. The extraction with aqueous methanol was optimized for whole root, powdered extract, and finished product (raw, tablet, and capsule matrixes) test articles. Root materials were treated with base to hydrolyze acidic malonyl ginsenosides to their neutral counterparts. Calibration curves for each ginsenoside were linear over the following ranges (microg/g): 5-394 for Rg1, 15-1188 for Re, 39-2981 for Rb1, 6-499 for Rc, 5-406 for Rb2, and 7-600 for Rd, all having a coefficient of determination (r2) of > or = 99.5%. The LOD for Rg1, Re, Rb1, Rc, Rb2, and Rd was determined to be 1.06, 1.25, 2.19, 1.24, 1.27, and 1.70 microg/mL, respectively. Quantitative determinations performed with eight test materials by two analysts over 3 days (n = 12) resulted in RSDr values that ranged from 1.11 to 7.61%.