HPLC法测定复方参龙胶囊中5个功效成分的含量

Determination of five effective components in Fufangshenlong capsules by HPLC

目的建立高效液相色谱法(HPLC)测定复方参龙胶囊5个功效成分三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd的含量。方法采用Shim-pack C18(250 mm×4.6 mm,5μm)色谱柱,以乙腈(A)-0.1%磷酸水溶液(B)为流动相,梯度洗脱(0-25 min,85%-80%B;25-60 min,80%-60%B;60-90 min,60%-45%B;90-100 min,45%-40%B);检测波长203 nm;流速为1.0 ml/min;柱温30℃;进样量10μl。在此条件测定复方参龙胶囊中5个功效成分三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd的含量。结果三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd的线性范围分别为22.60-452.00μg/ml(r=0.9998),37.36-747.20μg/ml(r=0.9997),32.87-657.30μg/ml(r=0.9996),46.55-931.00μg/ml(r=0.9997),29.93-598.65μg/ml(r=0.9997);平均回收率(n=6)分别为97.49%,97.41%,97.94%,97.44%,97.24%,RSD分别为1.68%,1.17%,0.84%,1.62%和1.00%。3批制剂中功效成分三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd,其平均含量与RSD分别为0.8736 mg/g和1.06%,2.7078 mg/g和1.04%,2.6323 mg/g和1.06%,3.0554 mg/g和1.64%,2.3132 mg/g和1.11%。结论该方法可用于复方参龙胶囊中三七皂苷R1、人参皂苷Rg1、人参皂苷Re、人参皂苷Rb1、人参皂苷Rd的含量测定,可作为本制剂的质量控制方法。

Objective To develop a HPLC method for determining the contents of notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,ginsenoside Rd in Fufangshenlong capsule.Methods The Shim-pack C18(250 mm×4.6 mm,5μm)column was used.The mobile phase was acetonitrile(A)-0.1% phosphoric acid solution(B)with gradient elution(0-25 min,85%-80%B;25-60 min,80%-60%B;60-90 min,60%-45%B;90-100 min,45%-40%B)at a flow rate of 1.0 ml/min,and the detection wavelength was set at 203 nm.The column temperature was 30℃.The injection volume was 10μl.The chromatographic conditions were used to determine the contents of notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,ginsenoside Rd in Fufangshenlong capsule.Results The linear ranges of notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,ginsenoside Rd were 22.60-452.00μg/ml(r=0.9998),37.36-747.20μg/ml(r=0.9997),32.87-657.30μg/ml(r=0.9996),46.55-931.00μg/ml(r=0.9997),29.93-598.65μg/ml(r=0.9997),respectively,the average recoveries(n=6)were 97.49%,97.41%,97.94%,97.44%,97.24%,respectively,and RSDs were 1.68%,1.17%,0.84%,1.62% and 1.00%,respectively.The average contents of notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,ginsenoside Rd in the three batches of preparations were 0.8736,2.7078,2.6323,3.0554,2.3132 mg/g,respectively,and their RSDs were 1.06%,1.04%,1.06%,1.64%,1.11% in three batches of Fufangshenlong capsules,respectively.Conclusion The established method can be used in determination of notoginsenoside R1,ginsenoside Rg1,ginsenoside Re,ginsenoside Rb1,ginsenoside Rd in Fufangshenlong capsule,and can be used as a quality control method for the preparation.