Determination of Diketo Aldehyde in Dihydroartemisinin Bulk Drug by Principal Component Reference Substances External Standard Method with Correction Factor / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 52-57, 2020.
Article
Dans Chinois
| WPRIM
| ID: wpr-857813
ABSTRACT
OBJECTIVE:
To establish a principal component reference substances external standard method with correction factor for the determination of impurity diketoal dehyde (DKA) in diketo aldehyde(DHA) bulk drug by selecting suitable liquid phase conditions.METHODS:
The chromatographic C18 column (4.6 mm×250 mm, 5 μm) was used; isometric elution was set at conducted using acetonitrile-water (37∶63) as elution condition; the flow rate was 1 mL•min-1; the detection wavelength was 216 nm; the column temperature was maintained at 15 ℃; the injection volume was 20 μL.RESULTS:
The DHA α peak and its impurity DKA were well separated. The average correction factor was 0.256 determined by three different chromatographic columns.CONCLUSION:
The correction factor of DKA in DHA is accurate and reliable. This method can be used for the quality control of DKA in DHA raw materials.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
langue:
Chinois
Texte intégral:
Chinese Pharmaceutical Journal
Année:
2020
Type:
Article
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