Quality evaluation of Guan‐Xin‐Ning injection based on fingerprint analysis and simultaneous separation and determination of seven bioactive constituents by capillary electrophoresis

The purpose of this study was to develop a comprehensive, rapid and practical capillary electrophoresis (CE) method for quality control (QC) of Guan‐Xin‐Ning (GXN) injection based on fingerprint analysis and simultaneous separation and determination of seven constituents. In fingerprint analysis, a...

Full description

Saved in:
Bibliographic Details
Published in:Electrophoresis 2017-12, Vol.38 (24), p.3168-3176
Main Authors: Xu, Liying, Chang, Ruimiao, Chen, Meng, Li, Lou, Huang, Yayun, Zhang, Hongfen, Chen, Anjia
Format: Article
Language:English
Subjects:
Biological activity
Buffers
Capillary electrophoresis
Constituents
Correlation coefficients
Drugs, Chinese Herbal - analysis
Drugs, Chinese Herbal - chemistry
Electrokinetics
Electrophoresis
Electrophoresis, Capillary - methods
Fingerprint analysis
Fingerprinting
Fingerprints
Guan‐Xin‐Ning injection
Hydrogen-Ion Concentration
Limit of Detection
Linear Models
Linearity
Quality assessment
Quality control
Reproducibility of Results
Separation
Simultaneous determination
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The purpose of this study was to develop a comprehensive, rapid and practical capillary electrophoresis (CE) method for quality control (QC) of Guan‐Xin‐Ning (GXN) injection based on fingerprint analysis and simultaneous separation and determination of seven constituents. In fingerprint analysis, a capillary zone electrophoresis (CZE) method with a running buffer of 30 mM borate solution (pH 9.3) was established. Meanwhile, ten batches of samples were used to establish the fingerprint electropherogram and 34 common peaks were obtained within 20 min. The RSD of relative migration times (RMT) and relative peak areas (RPA) were less than 5%. In order to further evaluate the quality of GXN injection, a micellar electrokinetic chromatography (MEKC) method was developed for simultaneous separation and determination of bioactive constituents. Seven components reached baseline separation with a running buffer containing 35 mM SDS and 45 mM borate solution (pH 9.3). A good linearity was obtained with correlation coefficients from 0.9906 to 0.9997. The LOD and LOQ ranged from 0.12 to 1.50 μg/mL and from 0.40 to 4.90 μg/mL, respectively. The recoveries ranged between 99.0 and 104.4%. Therefore, it was concluded that the proposed method can be used for full‐scale quality analysis of GXN injection.
ISSN:0173-0835
1522-2683
DOI:10.1002/elps.201700256