Quality Evaluation of Zhibai Dihuang Pills(Concentrated Pills)by HPLC Fingerprint
10.6039/j.issn.1001-0408.2018.20.03
- VernacularTitle:HPLC指纹图谱法评价知柏地黄丸(浓缩丸)的质量
- Author:
Yajing LI
1
;
Fengqing WANG
;
Caixia XIE
;
Huiying XIE
;
Miao ZHANG
;
Jingwei LEI
Author Information
1. 河南中医药大学药学院
- Keywords:
HPLC;
Fingerprint;
Zhibai dihuang pills(concentrated pills);
Validity period
- From:
China Pharmacy
2018;29(20):2747-2751
- CountryChina
- Language:Chinese
-
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.
