Study on quality evaluation of garidi-5 by fingerprint combined with quantitative analysis of multi-components by single marker (QAMS)

The basis of quality control of Garidi-5 preparations from different manufacturers is provided by qualitative and quantitative analysis of multiple components of Garidi-5. With the combination of fingerprint and QAMS mode, A caprisil C-18 (250 mm x 4.6 mm, 5um) column was used with acetonitrile-tetrahydrofuran (25:15) (A)-0.2 mol/NH4Ac (B)-0.2% HAc (C) as mobile phase. The detection wavelength was 220 nm, 235 nm, 254 nm and 270 nm, respectively. The flow volume was 1.0 ml/min with the column temperature standing at 30 celcius, and the injection volume reaching to 10ul. With the High-Performance Liquid Chromatography-Ultraviolet method (HPLC), we established fingerprints of Garidi-5 preparations produced by different manufactures and identified 28 common peaks. Eleven components as Gallic acid, Ellagic acid, Benzoylaconitine, Benzoylhypaconitine, Benzoylmesaconitine, Aconitine, Hypaconitine, Mesaconitine, Costunolide, Dehydrocostuslactone and beta-Asarone were identified. There was no significant difference between the results of QAMS method taking a naturally occurring sesquiterpene lactone Costunolide as internal control and that of standard curve. From the perspective of composition, different quality of the same preparation which produced by different manufacturers is achieved. Accuracy, efficiency and feasibility of the experiment were accomplished with the QAMS method, which demonstrated obvious advantages compared with the standard curve method. It can be applied to the quality evaluation of Garidi-5 and lay the experimental foundation for the quality control of Garidi-5.

Automated summary

By utilizing High-Performance Liquid Chromatography-Ultraviolet method, this study established fingerprints of Garidi-5 preparations from different manufacturers, identified 11 key components, and compared the results of QAMS method with the standard curve method, ultimately achieving quality evaluation of different preparations.