Identification of major impurity in gemcitabine hydrochloride for injection by HPLC-QTOF / 中国药学杂志
Chinese Pharmaceutical Journal
;
(24): 739-742, 2013.
Article
in Chinese
| WPRIM
| ID: wpr-860403
ABSTRACT
OBJECTIVE:
To elucidate the structure of the major impurity in gemcitabine hydrochloride for injection.METHODS:
HPLC-QTOF-MS was adopted to analyze the structure of this impurity based on the fragmentation behavior of gemcitabine and this impurity. The separation was performed on a ZORBAX Eclipse XDB-C18(4.6 mm×250 mm, 5 μm) column. A mixture of 10% methanol and 90% 10 mmol·L-1 ammonium acetate(pH 5.7) was used as mobile phase. Flow rate was 1.0 mL·min-1. MS was performed under positive mode with 4.0 kV capillary voltage, 65 V skimmer, 310 kPa spray pressure, 11 L·min-1 drying gas (nitrogen) flow rate, 350°C drying gas temperature and 150 V fragmentor.CONCLUSION:
This study offers scientific data for studying the origin of the impurity of gemcitabine hydrochloride and improving its quality.
Full text:
Available
Index:
WPRIM (Western Pacific)
Type of study:
Diagnostic study
Language:
Chinese
Journal:
Chinese Pharmaceutical Journal
Year:
2013
Type:
Article
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