目的:建立HPLC波长切换法同时测定麝香心脑乐片中羟基红花黄色素A、3'-羟基葛根素、葛根素、3'-甲氧基葛根素、丹参素、丹酚酸B和丹参酮ⅡA的含量,为麝香心脑乐片质量的全面评价提供科学依据。方法:该药物70%甲醇提取液采用Hypersil BDS C18色谱柱(250 mm×4.6 mm,5 um),以乙腈(A)-0.4%磷酸溶液(B)为流动相,梯度洗脱。结果:羟基红花黄色素A、3'-羟基葛根素、葛根素、3'-甲氧基葛根素、丹参素、丹酚酸B和丹参酮ⅡA的线性范围分别在1.98~39.60、2.86~57.20、6.14~122.80、2.17~43.40、2.05~41.00、10.68~213.60、2.12~42.40 μg·mL-1内,与色谱峰峰面积呈良好的线性关系;平均加样回收率均在97.0%~99.8%,RSD均≤ 1.8%(n=6)。结论:本文建立的样品处理简便,测定结果准确,重复性好,可用于麝香心脑乐片质量评价。
Objective: To develop an HPLC wavelength switching method for determining the contents of hydroxysafflor yellow A, 3'-hydroxy puerarin, puerarin, 3'-methoxy puerarin, danshensu, salvianolic acid B and tanshinone ⅡA in Shexiang Xinnaole tablets simultaneously.It provides a scientific evaluation for comprehensive quality control of Shexiang Xinnaole tablets.Methods: The analysis of 70% methanol extract of the drug was performed on Hypersil BDS C18 (250 mm×4.6 mm, 5 um) chromatographic column;the mobile phase was acetonitrile(A) -0.4% phosphoric acid solution (B) with gradient elution.Results: The calibration curves of hydroxysafflor yellow A, 3'-hydroxy puerarin, puerarin, 3'-methoxy puerarin, danshensu, salvianolic acid B and tanshinoneⅡA showed good linearity in the range of 1.98-39.60, 2.86-57.20, 6.14-122.80, 2.17-43.40, 2.05-41.00, 10.68-213.60, 2.12-42.40 μg·mL-1, respectively.The average recoveries were 97.0%-99.8%;and RSDs were not more than 1.8% (n=6).Conclusion: An HPLC wavelength switching method has been successfully established for the simultaneous determination of 7 constituents in Shexiang Xinnaole tablets.The sample processing method is simple and the results are accurate and repeatable.It can be used for quality control of Shexiang Xinnaole tablets.