Abstract

A rapid and comprehensive ultra-performance liquid chromatography/tandem mass spectrometry (UPLC-MS/MS) method was developed for simultaneous determination of 10 major bioactive constituents in Mailuoning injection. Within 15 min, chromatographic separation was achieved on an Acquity UPLC BEH C18 column (50 mm × 2.1 mm I.D.) packed with 1.7 μm particles by a linear gradient elution. The analytes were monitored in a selected-ion reaction (SIR) mode with the electrospray ionization interface by the following ions: m/z 353.4 for isomers of chlorogenic acid, m/z 515.4 for isomers of 1,3-dicaffeoylquinic acid, m/z 179.2 for caffeic acid, m/z 192.9 for ferulic acid, m/z 503.2 for ecdysterone, and m/z 147.1 for cinnamic acid, respectively. The calibration curves of all analytes revealed good linear regression (r2 ≥ 0.9983) within test ranges. This method provided excellent sensitivity with LOQ and good precision with RSDs of intra- and interday variation less than 1.26% and 2.27%, respectively. The validated method was then applied to quantify the 10 major constituents in three batches of Mailuoning injection. The results indicated that the established method could be considered as an improved tool for quality control of Mailuoning injection.

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