UHPLC法同时测定并比较不同厂家、不同剂型益心舒制剂中7种成分含量

Objective: To establish a UHPLC method for simultaneous determination of seven components including ferulic acid, rosmarinic acid, lithospermic acid, senkyunolide I, salvianolic acid B, cryptotanshinone, and tanshinone II_A in Yixinshu preparations (益心舒制剂) with different dosage forms conducted by different manufacturers, laying a foundation for its further quality control promotion. Methods: Chromatographic separation was performed on a Waters Acquity HSS T3 column (100 mm × 2.1 mm, 1.8μm) at 37 ℃ of column temperature with 0.5% aqueous formic acid - acetonitrile as mobile phase for gradient elution. The flow rate was set at 0.4 mL/min, and the detection wavelength were set at 322 nm for ferulic acid, 280 nm for rosmarinic acid, lithospermic acid, senkyunolide I, salvianolic acid B, and 265 nm for cryptotanshinone, tanshinone II_A. Different batches, different manufacturers and different dosage forms of Yixinshu preparations were determined by the established method, then the results were compared and analyzed. Results: The seven components were separated clearly within 15 min. They presented good linear relationship in their linear ranges respectively, and all of the correlation coefficients were higher than 0.999 5. The RSD of precision, stability and repeatability were less than 2.46%. The average recoveries varied between 97.56% and 104.44% with RSD less than 3.72%. The contents of seven components in Yixinshu preparations produced by different manufacturers were different remarkably. Components which were originated from Salviae Miltiorrhizae Radix et Rhizoma (SMRR) presented a smaller difference relatively, but the other components that come from Chuanxiong Rhizoma (CR) exhibited significant difference. Conclusion: The established multi-component determination method is proved to be convenient, accurate and reliable enough. The quality of CR was estimated by quantitative data of chemical components, and the evaluation measurements of SMRR were well improved. On one hand it serves as a basis for the further promotion of overall quality control of Yixinshu preparations, on the other hand it provides a reference for the quality comparation of Yixinshu preparations conducted by different manufacturers or different dosage forms. © 2021, Editorial Office of Chinese Traditional and Herbal Drugs. All right reserved.

Simultaneous determination and comparation of seven components in Yixinshu preparations with different dosage forms conducted by different manufacturers using UHPLC

Objective To establish a UHPLC method for simultaneous determination of seven components including ferulic acid,rosmarinic acid,lithospermic acid,senkyunolideⅠ,salvianolic acid B,cryptotanshinone,and tanshinoneⅡA in Yixinshu preparations(益心舒制剂)with different dosage forms conducted by different manufacturers,laying a foundation for its further quality control promotion.Methods Chromatographic separation was performed on a Waters Acquity HSS T3 column(100 mm×2.1 mm,1.8μm)at 37℃of column temperature with 0.5%aqueous formic acid-acetonitrile as mobile phase for gradient elution.The flow rate was set at 0.4 m L/min,and the detection wavelength were set at 322 nm for ferulic acid,280 nm for rosmarinic acid,lithospermic acid,senkyunolide I,salvianolic acid B,and 265 nm for cryptotanshinone,tanshinoneⅡA.Different batches,different manufacturers and different dosage forms of Yixinshu preparations were determined by the established method,then the results were compared and analyzed.Results The seven components were separated clearly within 15 min.They presented good linear relationship in their linear ranges respectively,and all of the correlation coefficients were higher than 0.9995.The RSD of precision,stability and repeatability were less than 2.46%.The average recoveries varied between 97.56%and 104.44%with RSD less than 3.72%.The contents of seven components in Yixinshu preparations produced by different manufacturers were different remarkably.Components which were originated from Salviae Miltiorrhizae Radix et Rhizoma(SMRR)presented a smaller difference relatively,but the other components that come from Chuanxiong Rhizoma(CR)exhibited significant difference.Conclusion The established multi-component determination method is proved to be convenient,accurate and reliable enough.The quality of CR was estimated by quantitative data of chemical components,and the evaluation measurements of SMRR were well improved.On one hand it serves as a basis for the further promotion of overall quality control of Yixinshu preparations,on the other hand it provides a reference for the quality comparation of Yixinshu preparations conducted by different manufacturers or different dosage forms.