Determination of Five Index Components in Fuke Qianjin Tablets by Quantitative Analysis of Multi-compo-nents by Single Marker / 中国药师

ABSTRACT

Objective:To develop a method of quantitative analysis of multi-components by single marker ( QAMS) for the deter-mination of five index components in Fuke Qianjin tablets. Methods:Using erulic acid as the reference,an HPLC method with a Hy-persil GOLD C18 column (250 mm × 4. 6 mm,5 μm) was applied,the mobile phase was acetonitrile-0. 1% phosphoric acid with gradi-ent elution,the flow rate was 1. 0 ml·min-1 ,the detection wavelength was 254 nm,the column temperature was 30℃ and the injection volume was 10 μl. The relative correction factors among the five index components were detected by QAMS. The contents of the index components were determined respectively by an external standard method and QAMS, and the results were compared between them. The practicability and stability of QAMS were verified. Results:The established QAMS was used to determine the five index compo-nents in Fuke Qianjin tablets,and totally 6 batches of Fuke Qianjin tablets were determined. There were no significant differences be-tween the calculated values and the determined ones (P>0. 05). Conclusion:The QAMS method is simple,effective and accurate in determining the contents of five index components in Fukeqianjin tablets,which can be used for the quality control of Fuke Qianjin tab-lets and provide reference for the further studies.