Simultaneous Determination of Saponins and Lignans in Rat Plasma by UPLC- MS/MS and its Application to a Pharmacokinetic Study of Shenqi Jiangtang Granule.

Abstract

Shenqi Jiangtang Granule (SJG), a classical prescription of traditional Chinese medicine, is widely used to treat diabetes and its complications. Although, the clinical efficacy of SJG, is sufficient, the pharmacokinetic behavior of various substances in the plasma of SJG is unknown. The aim of this study was to investigate the plasma pharmacokinetics during absorption of SJG after oral administration in rats. A rapid and accurate ultra-high performance liquid chromatography/tandem mass spectrometry (UPLC- MS/MS) method was developed for the simultaneous determination of eight analytes in SJG, including gomisin D, schisandrin A, schisandrin B, schizandrol A, schizandrol B, ginsenoside Rd, ginsenoside Re and notoginsenoside Ft1. The analysis was carried out on a BEH C18 column (2.1 mm × 50 mm, 1.7 μm) with gradient elution at a flow rate of 0.2 mL/min in a mobile phase consisting of 0.1% formic acid water and acetonitrile. In addition, lignans and saponins were detected in positive ion mode and negative ion mode, respectively. Eight analytes in SJG, including gomisin D, schisandrin A, schisandrin B, schizandrol A, schizandrol B, ginsenoside Rd, ginsenoside Re and notoginsenoside Ft1, showed good linearity (R2 in the range of 0.9955 ~ 0.9999). The lower limit of quantification (LLOQ) was 5, 0.8, 0.8, 8, 0.8, 5, 0.6 and 10 ng/mL. The accuracy and precision of all analytes were at ±15%. Matrix effect and average extraction recovery were > 85%. All analytes performed well under four storage conditions. The results showed that in vivo absorption and exposure of gomisin D and ginsenoside Rd were better than other analytes, while schizandrol B and notoginsenoside Ft1 were poorly absorbed. This approach could be applied to study the pharmacokinetic characteristics of various analytes in plasma after oral administration of SJG in rats.