Establishment of HPLC Fingerprints for Feiqizhong Tablets and Simultaneous Determination of Fourteen Constituents.

Abstract

Aim: To establish the HPLC fingerprints for Feiqizhong tablets and to simultaneously determine fourteen contents in Feiqizhong tablets.

Methods: The analysis of the methanol extract of this drug was performed on a 30°C thermostatic Shimadzu Shim-pack GIST-C18 column (250 mm × 4.6 mm, 5 um), with the mobile phase comprising acetonitrile (A) -0.1% phosphoric acid (B) flowing at 1.0 mL/min in a gradient elution manner (0-10 min, 88% A; 10-30 min, 88%-50% A; 30-60 min, 50%-30% A; 60-65 min, 30% A; 65-70 min, 30%-88% A; 70-75 min, 88% A), and the detection wavelength was fixed at 246 nm.

Results: There were one hundred and five common peaks in the HPLC fingerprints of twenty batches of samples with similarities of more than 0.953. Among them, fourteen major active components with a high response value in the chromatogram were selected for quantification, including eupalinolide B, tanshinone IIA, chlorogenic acid, psoralenoside, isopsoralenoside, icariin, amygdalin, caffeic acid, calycosin-7-O-β-D-glucoside, salvianolic acid B, quercetin, psoralen, isopsoralen, and bakuchiol. Fourteen constituents showed good linear relationships within their own ranges (r ≥ 0.9985), whose average recoveries were 90.71-106.14% with RSD values of 0.23-1.22%.

Conclusion: A rapid and effective method for the separation and detection of components in Feiqizhong tablets is established, which can provide a basis for quality control and quantitative detection.