Simultaneous determination of ginsenoside Rg1 , Re and notoginsenoside R1 in human plasma by LC-MS/MS and its application in a pharmacokinetic study in Chinese volunteers.

ABSTRACT

A rapid and sensitive liquid chromatography-tandem mass spectrometry (LC-MS/MS) method has been developed and validated for simultaneous quantification of ginsenosides Rg1 , Re and notoginsenoside R1 in human plasma. Chromatography was performed on Capcell Pak C18 MG II column using a binary gradient using mobile phase A (5 mm ammonium formate solution) and B (methanol, containing 5 mm ammonium formate) at a flow rate of 0.3 mL/min. The entire chromatographic run time was 3.2 min. Quantification was achieved using multiple reaction monitoring in positive mode using API 3000. This method was validated in terms of specificity, linearity, precision, accuracy, matrix effect and stability. The calibration curves were linear in the concentration range of 0.020-5.00 ng/mL for ginsenosides Rg1 , Re and notoginsenoside R1 . The lower limit of quantification (LLOQ) of this method was 0.020 ng/mL. The intra-run and inter-run precision values were within 12.31% for ginsenoside Rg1 , 14.13% for ginsenoside Re and 11.46% for notoginsenoside R1 at their LLOQ levels. The samples were stable under all tested conditions. This method was successfully applied to study the pharmacokinetics of ginsenoside Rg1 and notoginsenoside R1 in 24 healthy volunteers following oral administration of 200 mg Sanqi Tongshu Enteric-Pellets Capsule.