Objective: To systemically evaluate the quality of Chinese compound Shuanghuanglian preparations (SHL

including capsules

granules

and oral liquid) based on the new concept of Q-Marker.Method: A qualitative analytical method of ultra performance liquid chromatography coupled with quadrupole time-of-flight tandem mass spectrometry (UPLC-Q-TOF-MS) was developed for quick identification of multi-constituentsin SHL. The source

specificity and related pharmacological effectsof chemical constituents were confirmed by analyzing biosynthetic pathway and component specificity. The qualitative assay was performed on a Waters CORTECS C18 column (2.1 mm×100 mm

1.6 μm) with the mobile phase consisting of acetonitrile (A) and 0.1% formic acid solution (B) as gradient elution at a flow rate of 0.25 mL·min-1. The column temperature was 45℃ and Q-TOF-MS was used in negative ion mode. Secondly

an HPLC-DAD analytical method was developed for simultaneously determining 22 major compound (including neochlorogenic acid

chlorogenic acid

caffeic acid

cryptochlorogenin acid

loganin

sweroside

secoxyloganin

rutin

scutellarin

luteoloside

forsythoside A

pinoresinol 4-O-β-D-glucopyranoside

isochlorogenic acid B

isochlorogenic acid A

isochlorogenic acid C

baicalin

forsythin

oroxylin A-7-O-glucuronid

wogonoside

baicalein

wogonin and oroxylin A) in Shuanghuanglian preparations. The quantitative assay was performed on Angilent Eclipse XDB-C18 with the mobile phase consisting of acetonitrile (A) and 3% methol and 0.1% formic acid solution (B) as gradient elution at a flow rate of 1.0 mL·min-1. The column temperature was at 30 ℃ and the optimum detection wavelength of DAD was set at 240

276 and 326 nm.Result: Based on the retention time and MS spectra

22 compounds (including iridoid glycosides

organic acids

lignans

and flavonoids) in Shuanghuanglian preparations were unambiguously identified by comparing with reference substances. In quantitative assay

the linear range of 22 detected compounds was fine(r>0.999 0)

and the overall recoveries ranged from 95% to 106%

with the RSD ranging from 2.0% to 4.6%. Chemical principal component analysis and modern pharmacological research of Marker were used to select the Q-Marker of Shuanghuanglian preparation.Conclusion: The UPLC-Q-TOF-MS approach was used to provide a rapid and effective qualitative method for identifying the chemical components of Shuanghuanglian preparations; the established HPLC-DAD was reliable and accurate to quantitatively analyze 22 active compounds in Shuanghuanlian preparations

further screen Q-Marker of Shuanghuanglian preparations

and provide reference for their comprehensive quality evaluation.