HPLC法测定心舒乐片中丹参酮Ⅱ_A、羟基红花黄色素A、苦杏仁苷

Determination of tanshinone Ⅱ_A,hydroxysafflor yellow A and amygdalin in Xinshule Tablets by HPLC

目的建立测定心舒乐片(丹参、葛根、红花、桃仁、郁金等)中丹参酮ⅡA、羟基红花黄色素A、苦杏仁苷的HPLC方法,为心舒乐片的质量研究提供依据。方法采用HPLC法,Eclipse XDB-C18柱(5μm,4.6 mm×150 mm);测定丹参酮ⅡA采用流动相甲醇-水(75∶25),检测波长为270 nm;测定羟基红花黄色素A采用流动相甲醇-乙腈-0.7%磷酸溶液(26∶2∶72),检测波长为403 nm;测定苦杏仁苷采用流动相甲醇-水(20∶80),检测波长为210 nm。结果丹参酮ⅡA在0.008～0.040μg,羟基红花黄色素A在0.026～0.132μg,苦杏仁苷在0.017～0.084μg范围内呈良好线性关系;平均回收率:丹参酮ⅡA为97.61%,羟基红花黄色素A为98.04%,苦杏仁苷为98.44%;RSD:丹参酮ⅡA为0.78%,羟基红花黄色素A为1.09%,苦杏仁苷为0.82%。结论建立的方法测定快速,定量准确,重复性、稳定性较好,回收率高,可用于心舒乐片的测定。

AIM To establish an HPLC for determining tanshinone ⅡA, hydroxysafflor yellow A and amygda- lin in Xinsule Tablets （Salviae miltiorrhizae Radix et Rhizome, Puerariae lobatae Radix, Carthami Flos, Persicae Semen, Curcumae Radix）. METHODS Eclipse XDB-C18 （5 μm, 4. 6 mm× 150 mm） column was used. Tanshi- none ⅡA was determined with the moblie phase of methanol-water （75 ： 25 ）, and detection wavelength of 270nm. Hydroxysafflor yellow A was determined with the moblie phase of methanol-acetontrile-70% phosphoric acid （26 ： 2 ： 72） and detection wavelength of 403 nm. Amygdalin was determined with the moblie phase of methanol-water （20 ： 80） and detection wavelength of 210 nm. RESULTS The linear ranges were 0. 008 -0. 040μg for tanshi- none I1 A, 0. 026 --0. 132 μg for hydroxysafflor yellow A and 0. 017 -0. 084 μg for amygdalin. Their average re- coveries were 97.61% , 98.04% and 98.44% , respectively. Their RSDs were 0.78% , 1.09% and 0. 82% , respectively. CONCLUSION The method is rapid, accurate, reproducible, stable and has high recovery. It can be used for quality control of Xinshule Tablets.