Quality evaluation of Guan‐Xin‐Ning injection based on fingerprint analysis and simultaneous separation and determination of seven bioactive constituents by capillary electrophoresis. Issue 24 (26th September 2017)

• Record Type: Journal Article
• Authors: Xu, Liying; Chang, Ruimiao; Chen, Meng; Li, Lou; Huang, Yayun; Zhang, Hongfen; Chen, Anjia
• Is Part Of: Electrophoresis. Volume 38:Issue 24(2017)
• Page Start: 3168
• Page End: 3176
• Publication Date: 2017-09-26
• Subjects: Capillary electrophoresis -- Fingerprint analysis -- Guan‐Xin‐Ning injection -- Quality control -- Simultaneous determination; Electrophoresis -- Periodicals; Electrophoresis -- Periodicals; 541.372
• DOI: 10.1002/elps.201700256
• Languages: English
• ISSNs: 0173-0835

Abstract

Abstract: 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.