目的:建立复方丹参片(丹参,三七,冰片)中三七有效成分的高效液相色谱测定方法。方法:采用Kromasil C18(5μm,250mm×4.60mm)色谱柱;流动相:乙腈-0.05%磷酸水溶液梯度洗脱(0~12min:乙腈浓度为22%;12~20min:乙腈的浓度由22%递升至28%;20~60min:乙腈的浓度由28%递升至43%);流速为1mL/min,检测波长为203nm。结果:三七皂苷R1和人参皂苷Rg1、Re、Rb1的线性范围分别为0.326~3.260μg(r=0.9997),0.890~8.900μg(r=0.9998),0.144~1.440μg(r=0.9996),0.940~9.400μg(r=0.9998);平均加样回收率(n=6)分别为99.08%,98.36%,97.54%,96.07%,RSD分别为4.41%,1.64%,2.77%,1.12%。结论:本测定方法简便可行、重复性好,可用于本制剂中三七多种有效成分的含量测定。
AIM: To establish the method for determing effective components of notoginsenoside in Compound Danshen Tablets(Radix et Rhizoma Salviae miltiorrhizae, Radix et Rhizoma Notoginseng, Borneolum Syntheticum ) by RP-HPLC. METHODS : The contents of notoginsenoside R1 , ginsenoside Rg1 , ginsenoside Re and ginsenoside Rb1 were simultaneously determined by an HPLC system with Kromasil C18 (5 μm, 250 mm ×4.60 mm), the mobile phase was CH3CN-0.05% HaPO4 ( CH3CN 0-12 min:22% ; 12-20 min:22%-28% ;20-60 min:28%-43% ). The flow rate was 1 mL/min. The detection wavelength was set at 203 nm. RESULTS : The linear ranges of notoginsenoside R1 , ginsenoside Rg1 , ginsenoside Re and ginsenoside Rb1 were 0. 326-3. 260 μg( r = 0. 999 7), 0. 890- 8. 900 μg ( r = 0. 999 8 ), 0. 144-1. 440 μg ( r = 0. 999 6 ) , 0. 940-9. 400 μg ( r = 0. 999 8 ) , respectively. Their average recoveries(n =6) were 99.08% , 98.36%, 97.54% and 96.07%, corresponding RSD were 4.41%, 1. 64%, 2.77% and 1.12%, respectgively. CONCLUSION: The results indicate that the HPLC method is simple, accurate, highly selective and reproducible, thus it could be used as quality control in the preparation of Compound Danshen Tablets.