Abstract
In this study, a rapid and comprehensive ultra-performance liquid chromatography/tandem mass spectrometry (UPLC-MS/MS) method was developed for simultaneous determination of nine major bioactive constituents in Dengzhanxixin injection. The chromatographic separations were obtained on an Acquity UPLC BEH C18 column (50 mm × 2.1 mm I.D., 1.7 μm) by a linear gradient elution with the mobile phase consisting of A (water and 0.6% acetic acid) and B (acetonitrile and 0.6% acetic acid). The total analytical run time was relatively short (14 min). The analytes and two internal standards (ISs) were all monitored in a selected-ion reaction (SIR) mode with a negative electrospray ionization (ESI−) interface. The calibration curves of all analytes revealed good linear regression (r2 ≥ 0.9972) within test ranges. This method provided good precision with RSD of intra- and interday variation less than 1.26% and 2.51%, respectively. The validated method was then applied to quantify the nine major constituents in six batches of Dengzhanxixin injection, and the results indicated that the established method could be considered as an improved tool for quality control of Dengzhanxixin Injection.
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