Abstract
An ultra-high-performance liquid chromatography-electrospray ionization tandem mass spectrometry (UHPLC-ESI-MS/MS) method was developed for simultaneous determination of fifteen constituents in Jitai tablet (JTT), a complex Traditional Chinese Medicine prescription (TCMP) used in treating opiate addiction. Benefitting from a small particle size (1.8 µm) C18 column, accelerated analysis with satisfactory resolution, sensitivity and selectivity were achieved in a single run within 7 min with linear gradient elution of acetonitrile-0.1% (v/v) formic acid in water. The analytical signal was obtained by multiple reaction monitoring transitions via electrospray ionization source operating in both positive and negative ionization mode. The approach was validated for linearity, sensitivity, precision, repeatability, stability and recovery. All analytes showed good linearity over a wide concentration range (r > 0.99). The method limits ranged from 0.03 ng/mL to 19.35 ng/mL which are sensitive enough for quality control studies. The developed method was successfully applied to the simultaneous determination of fifteen constituents in JTT. In conclusion, our experimental results demonstrate that UHPLC-ESI-MS/MS is a useful approach for the overall quality assessment of complex TCMPs.
Highlights
Quality control in Traditional Chinese Medicine prescriptions (TCMPa) has made considerable progress with the development of analytical technology over the past decades [1,2,3]
The results suggested that ultrasonication with 50:50 methanol-water (v/v) for 30 min was a simple and effective procedure for the extraction of the fifteen compounds As follow-up work, the fifteen analytes selected in this paper were not merely selected based on the results of the plasma pharmacochemistry study and bioactivity screening of Jitai tablet (JTT), but the compounds with suitable therapeutic, bioactive, characteristic, main, synergistic, correlative, toxic and analytical properties in treating opiate addiction
Their pharmacological activity was stated in the introduction section, and the criteria for analyzing for these fifteen compounds was stated in part “2.5 Marker Compound Selection for Quality Control of Complex TCMP”
Summary
Quality control in Traditional Chinese Medicine prescriptions (TCMPa) has made considerable progress with the development of analytical technology over the past decades [1,2,3]. Many publications and official documents suggest their own different categories for seeking marker compounds, for instance, the eight categories suggested by Song et al in their recently published paper [7], and the four categories established by the European Medicines Agency (EMA) [8] All of these studies reference a single crude drug, and no methods could be found for TCMPs. a practical solution for marker compound selection of complex TCMPs should not merely link data from quality control to clinical safety and efficacy, and help providing evidence for the mechanism of action of this ancient medicinal substance
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