绞股蓝总苷分散片指纹图谱及3个成分的定量分析

Fingerprint and determination of three constituents in Jiaogulan Zonggan Dispersible Tablets by HPLC-ELSD

目的建立不同批次绞股蓝总苷分散片HPLc-ELsD指纹图谱，并对3种特征成分定量分析。方法采用HPLc-ELsD法，Phenomenex1unac18色谱柱（250mm×4．6mm，5μm），流动相为甲酸-异丙醇．水（1：8：91）和乙腈进行梯度洗脱，ELsD检测器；体积流量0．8mL/min；柱温25℃；进样量10此。结果10批绞股蓝总苷分散片指纹图谱中标示出20个特征峰；绞股蓝皂苷A、人参皂苷Rd、人参皂苷F：的线性范围分别为2．04～7．14μg（r=0．9994）、1．01～3．53μg（r=0．9995）、0．48～1．69μg（r=0．9997）；平均加样回收率分别为98．67％、98．40％、98．92％、RsD分别为1．10％、0．78％、1．30％。结论该方法简便，重复性好，精密度高，可用于绞股蓝总苷分散片生产过程的质量控制与制剂质量控制。

AIM To establish the HPLC-ELSD fingerprint of Jiaogulan Zonggan Dispersible Tablets （total saponins from gynostemma） and to quantify three marker components. METHODS The determination was per formed on a C18 column （250 mm x4. 6 mm, 5 μm） , the mobile phase consisted of formic acid-isopropanol-water （ 1 ： 8 ： 91 ） and acetonitrile at a flow rate of 0. 8 mL/min with 30 ℃ column temperature and 10 μL sample size. ELSD was used as the detector. RESULTS Twenty characteristic peaks were marked in HPLC-ELSD fingerprint from different batches of Jiaogulan Zonggan Dispersible Tablets. The contents of gypenoside A, ginsenoside Rd and ginsenoside F2 showed good linear relationship in the ranges of 2. 04 -7. 14 μg （r = 0. 999 4）, 1.01 -3.53 μg （ r = 0. 999 5 ） and 0.48 - 1.69 μg （ r = 0. 999 7 ）, respectively. Their average recoveries were 98.67% （ RSD 1.10% ）, 98.40% （ RSD 0.78% ） and 98.92% （ RSD 1.40% ）, respectively. CONCLUSION This method is simple, accurate and reproducible, which can be used for controlling the quality of Jiaogulan Zonggan Dispers- ible Tablets and its production control.