TKM Converging Research Division, Korea Institute of Oriental Medicine, Daejeon, Korea.
Arch Pharm Res. 2012 Oct;35(10):1785-91. doi: 10.1007/s12272-012-1011-0. Epub 2012 Nov 9.
Soshiho-tang, one of the herbal prescriptions, has been used in treatment of chronic liver disease. In this study, the efficient high-performance liquid chromatography coupled with diode array detection and electrospray ionization tandem mass spectrometry (HPLC-DAD-ESI-MS) method was developed and validated for simultaneous determination of six marker compounds, namely homogentisic acid, baicalin, glycyrrhizin, saikosaponin A, 6-gingerol and ginsenoside Rg3 in Soshiho-tang. The analysis of six marker compounds was carried out using a C(18) column (SHISEIDO S-5 μm, 4.6 mm I.D. × 250 mm) and gradient elution with water - 0.1% trifluoroacetic acid and acetonitrile. The analytical method was validated for linearity, precision and accuracy. Calibration curve for six marker compounds showed good linear regression (r(2) > 0.9996). The limits of detection (LOD) and limits of quantification (LOQ) for analytes were ranged from 0.04 to 0.16 μg/mL and 0.12 to 0.47 μg/mL, respectively. The relative standard deviations (RSD%) of the precision test, intra- and inter-day, were less than 0.32% and 0.10%, respectively. All recoveries of the six marker compounds were ranged from 100.05% to 102.25% with RSD less than 0.63%. These results have shown that this developed method was efficient for the quality evaluation of Soshiho-tang.
芍药汤是一种草药方剂，已被用于治疗慢性肝病。本研究建立并验证了一种高效液相色谱-二极管阵列检测-电喷雾串联质谱（HPLC-DAD-ESI-MS）法，用于同时测定芍药汤中 6 种指标性成分，即反式-对-羟基桂皮酸、黄芩苷、甘草酸、柴胡皂苷 A、6-姜辣素和人参皂苷 Rg3。采用 C18 柱（SHISEIDO S-5μm，4.6mmID×250mm），以水-0.1%三氟乙酸和乙腈为流动相进行梯度洗脱，对 6 种指标性成分进行分析。对该分析方法进行了线性、精密度和准确度验证。6 种指标性成分的校准曲线均具有良好的线性回归（r2>0.9996）。各分析物的检测限（LOD）和定量限（LOQ）范围分别为 0.04-0.16μg/mL和 0.12-0.47μg/mL。精密度试验、日内和日间的相对标准偏差（RSD%）均小于 0.32%和 0.10%。6 种指标性成分的回收率均在 100.05%-102.25%之间，RSD 小于 0.63%。这些结果表明，该方法可用于芍药汤的质量评价。
