一测多评法测定复方人参片中的8种苷类成分

Determination of Eight Glycosides in Compound Ginseng Tablets by QAMS

关键词:  高效液相色谱法  苷类  复方人参片  一测多评

Key words:  HPLC  glycosides  Compound Ginseng tablets  QAMS

摘要:

目的 建立一测多评法（quantitative analysis single-marker，QAMS）测定复方人参片中8种苷类成分的含量。方法 采用Agilent XDB-C₁₈色谱柱（4.6 mm×250 mm，5 μm），流动相水（A）-乙腈（B），梯度洗脱；体积流量1.0 mL·min^-1；检测波长203 nm；柱温：25℃。以人参皂苷Rb₁为内标，计算人参皂苷Rg₁、人参皂苷Re、淫羊藿苷、人参皂苷Rc、人参皂苷Rb₂、人参皂苷Rb₃、人参皂苷Rd的相对校正因子，测定其含量。结果 8种成分在各自范围内线性关系良好（r ≥ 0.999 0），加样回收率为95.6%~104.4%，RSD为1.22%~2.73%，QAMS测定结果与外标法测定结果无显著性差异。结论 该法准确度、灵敏度高、专属性好、操作简单、重复性好。

Abstract:

OBJECTIVE To establish a quantitative of multi-components by single maker for the content determination of eight glycosides in Compound Ginseng tablets.METHODS The analysis of methanol extract of this drug was performed on a 25℃ Agilent XDB -C₁₈ column(4.6 mm×250 mm, 5 μm), with the mobile phase of water(A)-acetonitrile(B) flowing at 1.0 mL·min^-1 in a gradient elution manner, and the detection wavelength was set at 203 nm. Ginsenoside Rb1 was used as the internal reference substance, RCFs of ginsenoside Rg1, ginsenoside Re, icarrin, ginsenoside Rc, ginsenoside Rb2, ginsenoside Rb3, ginsenoside Rd was calculated. The contents of seven consitituents were determined by both external standard and QAMS. The validity of the QAMS method was evaluated by comparison of their quantitative results of both methods.RESULTS Eight consitituents showed good linear relationships within their own ranges (r ≥ 0.999 0), whose average recoveries were 95.6%-104.4% with the RSDs of 1.22%-2.73%. The results obtained by QAMS method approximated those obtained by external standard method.CONCLUSION The method of QAMS turns out to be simple, sensitive, accurate, specific and reproducible in the quality control of Compound Ginseng tablets.