Abstract:
OBJECTIVE To establish the HPLC fingerprint of Lanqin granules for the quality evaluation and control.
METHODS HPLC fingerprint of Lanqin granules was performed on a Waters Xselect HSS T3 C
18 column(4.6 mm×150 mm, 3.5 μm). The mobile phase was acetonitrile(A)-0.05mol·L
-1 ammonium formate(containing 0.05% formic acid)(B) with gradient elution, with the flow rate of 0.7 mL·min
–1, the column temperature was 35 ℃ and the detection wavelength was 254 nm. The material basis of Lanqin granules was studied and the characteristic peaks were identified by HPLC-Orbitrap-MS/MS. Similarity of 54 batches samples from 2 manufactures were evaluated by chromatographic fingerprint similarity evaluation software.
RESULTS The HPLC fingerprint of Lanqin granules was established and 30 common peaks were identified. The detected peaks belonged to Isatidis Radix, Scutellariae Radix, Gardeniae Fructus, Phellodendri Chinensis Cortex and Sterculiae Lychnophorae Semen, respectively. The similarity values of 54 batches samples ranged from 0.92 to 0.99. Similarity evaluation results showed that the difference between enterprises was small, the overall quality was good.
CONCLUSION The established fingerprint can quickly and characteristic comprehensively evaluate the quality of Lanqin granules.