Study on HPLC Fingerprinting and Multi-index Content Determination of Jianpi Wuwei Pill
Objective To establish the fingerprint and multi-index content determination method of the Mongolian drug Jianpi Wuwei Pill,providing a basis for its quality control.Methods Sepax HP-C18 column(4.6 mm × 250 mm,5 μm)was used,with acetonitrile-0.1％formic acid solution as the mobile phase for gradient elution at a flow rate of 1 mL/min.The detection wavelength was set at 254 nm,and the column temperature at 28 ℃.A sample quantity of 10 μL was used to establish the fingerprint map of 10 batches of Jianpi Wuwei Pill,and the content of 7 components was determined using the one-sample multi-evaluation method.Results The HPLC fingerprint map of Jianpi Wuwei Pill identified 11 common peaks,recognizing 7 components including protocatechuic acid,gallic acid,picroside Ⅰ,picroside Ⅱ,ellagic acid,alantolactone and isoalantolactone.The content values was the 7 components obtained through the one-sample multi-evaluation method were compared with the external standard method,showing consistent results for the content determination of 10 batches of Jianpi Wuwei Pill.Method validation demonstrated good linear relationships(r ≥ 0.999)and an average sample recovery rate was 96.68％to 104.44％.Conclusion The established fingerprint map and multi-index content determination method are accurate,efficient and characteristic,providing effective reference for the quality evaluation and clinical application of Jianpi Wuwei Pill.
Jianpi Wuwei Pillfingerprint mapquantitative analysis of multi-components by single-marker(QAMS)high performance liquid chromatography
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