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 Rg 1 , Re and notoginsenoside R 1 in human plasma. Chromatography was performed on Capcell Pak C 18 MG II column using a binary gradient using mobile phase A (5 m m ammonium formate solution) and B (methanol, containing 5 m m 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 Rg 1 , Re and notoginsenoside R 1 . 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 Rg 1 , 14.13% for ginsenoside Re and 11.46% for notoginsenoside R 1 at their LLOQ levels. The samples were stable under all tested conditions. This method was successfully applied to study the pharmacokinetics of ginsenoside Rg 1 and notoginsenoside R 1 in 24 healthy volunteers following oral administration of 200 mg Sanqi Tongshu Enteric‐Pellets Capsule.