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.
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| ID: wpr-812658
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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.
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Asunto principal:
Saponinas
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Espectrometría de Masas
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Espectroscopía de Resonancia Magnética
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Estructura Molecular
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Química
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Contaminación de Medicamentos
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Cromatografía Líquida de Alta Presión
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Métodos
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En
Revista:
Chinese Journal of Natural Medicines (English Ed.)
Año:
2013
Tipo del documento:
Article