肝宝胶囊HPLC指纹图谱建立及5种成分同时测定

目的建立肝宝胶囊(青果、虎杖、谷芽等)HPLC指纹图谱,并同时测定5种成分的含有量。方法该药物甲醇提取液的分析采用Platisil-C₁₈色谱柱(4.6 mm×250 mm,5μm);流动相乙腈-0.1%磷酸,梯度洗脱;体积流量1 mL/min;柱温30℃;检测波长305 nm。结果 13批样品指纹图谱中有19个共有峰,相似度大于0.9。没食子酸、芥子碱硫氰酸盐、虎杖苷、白藜芦醇、大黄素分别在45.19～497.05 ng (r=0.999 4)、23.89～262.81 ng (r=0.999 6)、194.26～2 136.81 ng (r=0.999 5)、4.45～48.95 ng (r=0.999 6)、8.82～97.05 ng (r=0.999 6)范围内线性关系良好,平均加样回收率(RSD)分别为99.85%(1.56%)、99.46%(1.98%)、99.97%(1.42%)、98.95%(2.13%)、99.67%(2.01%)。结论该方法简便、稳定、可靠,可用于肝宝胶囊的质量控制。

Establishement of HPLC fingerprints of Ganbao Capsules and simultaneous determination of five constituents

AIM To establish the HPLC fingerprints of Ganbao Capsules(Canarii Fructus,Polygoni cuspidati Rhizoma et Radix,Setariae Fructus Germinatus,etc.)and to simultaneously determine the contents of five constituents.METHODS The analysis of methanol extract of this drug was performed on a 30 ℃ thermostatic Platisil-C18 column(4.6 mm×250 mm,5 μm),with the mobile phase comprising of acetonitrile-0.1% phosphoric acid flowing at 1 mL/min in a gradient elution manner,and the detection wavelength was set at 305 nm.RESULTS There were nineteen common peaks in the fingerprints of thirteen batches of samples with the similarities of more than 0.90.Gallic acid,sinapine thiocyanate,polydatin,resveratro and emodin showed good linear relationships within the ranges of 45.19-497.05 ng(r=0.999 4),23.89-262.81 ng(r=0.999 6),194.26-2 136.81 ng(r=0.999 5),4.45-48.95 ng(r=0.999 6)and 8.82-97.05 ng(r=0.999 6),whose average recoveries(RSDs)were 99.85%(1.56%),99.46%(1.98%),99.97%(1.42%),98.95%(2.13%)and 99.67%(2.01%),respectively.CONCLUSION This simple,stable and reliable method can be used for the quality control of Ganbao Capsules.