摘要
目的:建立HPLC法同时测定心可宁胶囊中丹参素、原儿茶醛、丹酚酸B的含量,以更好地控制丹参的质量。方法:采用Alltech C18(4.6 mm×150 mm,5μm)色谱柱,流动相为甲醇-0.5%冰醋酸梯度洗脱,流量1.0 mL.min-1,检测波长280 nm。结果:丹参素、原儿茶醛、丹酚酸B的线性范围分别为0.190 6～1.906 2μg(r=0.999 8)、0.021 3～0.213 1μg(r=1)、0.172 7～1.727 7μg(r=1);平均回收率(n=6)分别为97.6%(RSD=1.5%)、102.2%(RSD=1.2%)、99.5%(RSD=1.6%)。结论:本方法简便、灵敏、准确,重现性好,可用于该制剂的质量控制。
Objective ： To establish an HPLC method for the determination of danshensu, protocatechuic aldehyde and salvianolic acid B in Xinkening Capsules in order to control the quality of Salviae Mihiorrhizae Radix et Rhizoma used in Xinkening Capsules. Method ： The samples were separated on a Alhech C18 column（4. 6 mm× 150 mm,5 μm） ,by a gradient elution using methanol - 0.05% acetic acid as mobile phase at a flow rate of 1.0 mL .min^ -1. The UV detection wavelength was set at 280 nm. Results ： The standard calibration curves of danshensu, protocatechuic aldehyde and salvianolic acid B were linear in the ranges of 0. 190 6-1. 906 2 μm（r = 0. 999 8 ） ,0. 021 3-0. 213 1 μm（ r = 1 ） ,0. 172 7 - 1. 727 7 μm （ r = 1 ） , respectively. The average recoveries （ n = 6 ） were 97.6% （ RSD = 1.5% ） , 102.2% （ RSD = 1.2% ） ,99. 5% （ RSD = 1.6% ）, respectively. Conclusion： The method is simple, accurate, sensitive and reproducible, it can be used for the determination of three effective components in Xinkening capsules.
出处
《中国药品标准》
CAS
2012年第4期251-255,共5页
Drug Standards of China
