柴胡口服液工艺药渣中5种柴胡皂苷的含量测定

Determination of Five Saikosaponins in the Leftovers from the Preparation Process of Radix Bupleuri Oral Liquid

目的建立HPLC测定柴胡口服液工艺药渣中5种柴胡皂苷含量的方法。方法 Hypersil C18色谱柱(4.6 mm×250mm,5μm);以乙腈和水为流动相,梯度洗脱;流速:1.0 mL.min-1;柱温:30℃;检测波长:210,254 nm。结果柴胡皂苷a、c、h、b1、b2的线性范围分别为:0.23～4.6μg(r=0.999 8)、0.11～2.2μg(r=0.995 6)、0.15～3.0μg(r=0.999 6)、0.35～3.5μg(r=0.999 3)、0.71～7.1μg(r=0.999 7),平均回收率分别为98.10%(RSD=1.73%)、100.60%(RSD=2.25%)、98.60%(RSD=2.08%)、97.27%(RSD=0.83%)、99.70%(RSD=2.26%)。结论该方法简便可靠,可用于柴胡口服液工艺药渣中柴胡皂苷的含量测定。

OBJECTIVE To establish an HPLC method for determination of five saikosaponins in the leftovers from the prepara- tion process of Radix Bupleuri Oral Liquid. METHODS The five constituents were analyzed on an Hypersial Cl8 column （4. 6 mm × 250 mm, 5 μm） by gradient elution using acetonitrile-water as the mobile phase. The flow rate was 1.0 mL · min-1. The column tem- perature was 30℃. The detection wavelengths were set at 210 and 254 nm. RESULTS The calibration curves were linear in the ranges of 0. 23 -4.6 μg （r =0. 999 8） , 0. 11 -2.2 μg （r =0.995 6）, 0. 15 -3.0 μg （r =0. 999 6） , 0.35 -3.5μg （r =0.999 3） and 0. 71 -7.1 μg （r =0. 999 7） for saikosaponin a, c, h, b1 and b2 , respectively. The average recoveries of saikosaponin a, c, h, bl and b2were 98.10% with RSD of 1.73%, 100. 60% with RSD of 2. 25%, 98.60% with RSD of 2.08%, 97.27% with RSD of 0. 83% and 99.70% with RSD of 2.26%, respectively. CONCLUSION This method is simple and reliable, which can be used for the determination of saikosaponin a, c, h, b1 and b2in the leftovers from the preparation process of Radix Bupleuri Oral Liquid.