A comprehensive quality evaluation strategy of Mailuoning oral liquid based on fingerprint, qualitative and quantitative analyses.

In order to obtain comprehensive quality evaluation of one traditional Chinese patent medicine of Mailuoning oral liquid (MLN), one smart strategy combined by fingerprint, qualitative and quantitative analyses were carried out in this study. Firstly, the fingerprints of MLN were established by HPLC-UV and HPLC-ELSD, and explained the similarity of twenty-seven batches of MLN by similarity analysis (SA). Secondly, qualitative analysis was performed by high performance liquid chromatography coupled with quadrupole-time-of-flight mass spectrometry (HPLC-QTOF-MS/MS). A total of 60 compounds were identified or tentatively identified based on chemical standards and fragmentation information. Finally, the quantitative method based on UPLC combined with triple quadrupole mass spectrometry (UPLC-QqQ-MS/MS) was developed for the simultaneous determination of 40 target compounds. The results showed that MLN samples of different productive year were clearly discriminated and eight compounds (5-hydroxymethyl-2-furaldehyde, neochlorogenic acid, loganic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, isoacteoside, angoroside C) were selected as differential markers for MLN. In a word, this strategy including fingerprint, identification of chemical composition and multiple-component quantification could be well applied to modern quality evaluation of MLN, which could be valuable for the further quality control of more other traditional Chinese patent medicines. [Display omitted] • Fingerprint of Mailuoning oral liquid (MLN) was firstly established by HPLC-UV/ELSD. • Sixty constituents of MLN were characterized by HPLC-QTOF-MS/MS for the first time. • A sensitive UPLC-QqQ-MS/MS method of 40 components in MLN was firstly developed. • A strategy based on fingerprint, qualitative and quantitative analysis was proposed. [ABSTRACT FROM AUTHOR]