HPLC测定痹痛舒乐丸中的丹皮酚及峰纯度验证

Study on Quality standard of Bitongshule Pills

目的:建立痹痛舒乐丸的质量标准。方法:用高效液相色谱-紫外检测器对痹痛舒乐丸中的丹皮酚(徐长卿)进行含量测定,并采用液相色谱-串联质谱对主峰进行了纯度验证。结果:丹皮酚在0.123～6.16μg范围内呈线性关系,回归方程为Y=49971.49X-443488.87(r=0.99987),加样回收率为97.74%(n=6),主峰为单一物质,并无其他共洗脱物。结论:该方法简便准确、灵敏度高,可用于痹痛舒乐丸的质量控制。

Objective：To establish the quality control for Bitongshule Pills Methods：HPLC-UV was employed to quatitativly determinte the content of paeonol in Bitongshule Pills Results：The linear range of paeonol is 0.123～6.16μg,and the regression function is Y=49971.49X-443488.87（r=0.99987）,recovery is97.74%（n=6）,and the main peak was purity and no coeluent component detected Conclusion：The method is simple and specific for control of Bitongshule Pills.