Quality Assessment on Zhengtian Pills Based on HPLC Fingerprint and Multi-components Simultaneous Determination / 中国药师

ABSTRACT

Objective:To establish an HPLC fingerprint and determine five compounds in Zhengtian pills to provide reference for the effective quality control.Methods:The analysis was carried out on an Agilent XDB-C18analytical column (250 mm × 4.6 mm,5 μm) with gradient elution by acetonitrile (A) -0.19% phosphoric acid solution (B) (0-8 min,10 % A→15% A;10-23 min,15 % A→45 % A;23-50 min,45 % A;50-60 min,45 % A→70 % A;60-70 min,70 % A),the detection wavelength was 310 nm and the flow rate was 1.0 ml/min. The column temperature was 30 ℃. Similarity evaluation was used to evaluate the fingerprints of 12 batches of Zhengtian pills,and five marker components were quantified. Results:There were 33 common peaks in the fingerprints of twelve batches of Zhengtian pills, and five of them (ferulic acid, prim-O-glucosylcimifugin, 5-O-methylvisammioside,imperatorin and isoimperatorin) were identified by comparison with the reference. The similarity of the 12 batches of samples was over 0.99. The linear ranges were 0.050-0.605 μg(r = 0.999 8),0.008-0.100 μg(r = 0.999 2), 0.013-0.150 μg(r = 0.998 6), 0.171- 2.049 μg(r = 0.999 7)and 0.113- 1.352 μg(r = 0.999 6) for ferulic acid, prim-O-glucosylcimifugin,5-O-methylvisammioside, imperatorin and isoimperatorin, respectively. The content of ferulic acid, prim-O-glucosylcimifugin,5-O-methylvisammioside,imperatorin and isoimperatorin was 0.78-0.84 mg/g,0.10-0.13 mg·g-1, 0.18-0.20 mg·g-1,2.44-2.51 mg·g-1and 1.70-1.78 mg·g-1in the 12 batches of samples, respectively. Conclusion:The established method has high sensitivity and specificity,which can be used for the quality control of Zhengtian pills.