Quality Evaluation of Zhibai Dihuang Pills(Concentrated Pills)by HPLC Fingerprint / 中国药房

ABSTRACT

OBJECTIVE:To establish the HPLC fingerprint of Zhibai dihuang pills(concentrated pills),and to evaluate its quality. METHODS:The determination was performed on Dikma Diamonsil C18column with mobile phase consisted of 0.1%acetic acid solution-methanol(gradient elution)at the flow rate of 1.0 mL/min. The detection wavelength was set at 260 nm,and column temperature was 30 ℃. The sample size was 10 μL. Using paeonol as reference,HPLC chromatograms of samples from A, B,C manufacturers within validity period and samples from manufacturer A within validity period and out of validity period were drawn. The similarity of HPLC chromatogram for samples from A,B and C manufacturers and samples from A manufacturer within validity period and out of validity period was evaluated by TCM Chromatogram Fingerprint Similarity Evaluation System (2004 A). Common peaks of HPLC chromatogram for 3 manufacturers sample within validity period were confirmed. RESULTS:There were 24,29 and 32 common peaks in HPLC chromatograms for each 10 batches of samples from manufacturer A,B and C within validity period,respectively. The similarity of corresponding HPLC chromatograms of samples from manufacturer A,B and C compared with control HPLC chromatography were all higher than 0.94 with good agreement. HPLC chromatograms of sample from A manufacturer within validity period had good agreement with that from A manufacturer out of validity period. CONCLUSIONS:Established HPLC fingerprint analysis method can represent the quality of Zhibai dihuang pills (concentrated pills),but cannot effectively identify the expired samples.