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
in Zh
| WPRIM
| ID: wpr-857813
Responsible library:
WPRO
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.
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Index:
WPRIM
Language:
Zh
Journal:
Chinese Pharmaceutical Journal
Year:
2020
Type:
Article