中文摘要：

建立了反相高效液相色谱分离、质谱定性、紫外检测定量测定康肾颗粒中葛根素含量的方法。采用YMC．ODS色谱柱（4．6mmi．d．×100mm，10μm），选用甲醇（含0．1％三氟醋酸）和水（含0．1％三氟醋酸）体系为流动相，非线性梯度洗脱分离，流速1．0mL／min，检测波长250nm；用基质辅助激光解吸离子化飞行时间质谱（MALDI—TOFMS）分析鉴定对照品和样品的馏分，在确定目标峰后进行紫外检测定量测定。结果表明，葛根素在0．132～1．32μg范同内其峰面积与进样量呈良好的线性关系（r=0．9997），平均加标回收率高于103％，相对标准偏差低于2．0％（n=6）。应用该方法测定康肾颗粒中葛根素，其平均含量为3．09mg／g。该方法简单、快速、重现性好.

英文摘要：

Kangshen granule, containing 12 kinds of traditional Chinese medicine, has complex composition. A new method for the determination of puerarin in Kangshen granule was developed using reversed-phase high performance liquid chromatography coupled with matrix assisted laser desorption ionization time of flight mass spectrometry and ultraviolet detection （ RPHPLC/MALDI-TOF MS/UV）. The sample was separated by RP-HPLC with a non-linear gradient elution, and then was qualitatively detected by mass spectrometry to identify the puerarin peak. The chromatographic process was performed on a YMC-ODS column under the optimized conditions with a mobile phase consisting of methanol, water and 0. 1% TFA, and detected at 250 nm. The linear range of puerarin was from 0. 132 to 1.32μg （ r = 0. 999 7 The recovery was higher than 103% and the relative standard deviation was lower than 2.0% （n = 6）. The puerarin content in Kangshen granule sample was determined and the puerann content was 3.09 mg/g. The method is simple and feasible for the determination of puerarin with a good repeatability. The method can be used for quality control of Kangshen granule.