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

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.