Isolation, structure characterization and quantification of related impurities in asperosaponin VI / 中国天然药物
Chinese Journal of Natural Medicines (English Ed.)
; (6): 419-426, 2013.
Article
in En
| WPRIM
| ID: wpr-812658
Responsible library:
WPRO
ABSTRACT
AIM@#To study the related impurities in asperosaponin VI bulk drug and to develop a high performance liquid chromatography (HPLC) method for the determination of asperosaponin VI and its related impurities.@*METHODS@#The related impurities were detected in asperosaponin VI bulk drug by a newly developed HPLC method, obtained by ODS column chromatography and semi-preparative HPLC methods, and the structures were elucidated by TOF-MS, IR, and NMR techniques. The HPLC method was validated according to ICH guidelines for asperosaponin VI and its related impurities.@*RESULTS@#Seven related impurities (Imp 1-7) were isolated from asperosaponin VI bulk drug. Impurity 3 was found to be a mixture of two epimers, and was first reported in the paper. The validation results showed good sensitivity, specificity, linearity (r(2) ≥ 0.997 9), precision (RSD < 5.0%), accuracy (recoveries in the range of 94.61%-106.51%) and robustness.@*CONCLUSION@#The developed HPLC method is suitable for the quality control of asperosaponin VI bulk drug.
Key words
Full text:
1
Database:
WPRIM
Main subject:
Saponins
/
Mass Spectrometry
/
Magnetic Resonance Spectroscopy
/
Molecular Structure
/
Chemistry
/
Drug Contamination
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Chromatography, High Pressure Liquid
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Methods
Language:
En
Journal:
Chinese Journal of Natural Medicines (English Ed.)
Year:
2013
Document type:
Article