Determination of Related Substances in Cabazitaxel Injection by HPLC / 中国药房
China Pharmacy
;
(12): 1209-1212, 2018.
Article
in Chinese
| WPRIM
| ID: wpr-704766
ABSTRACT
OBJECTIVE:
To establish a method for the determination of related substances in Cabazitaxel injection.METHODS:
HPLC method was used. The determination was performed on Agilent Eclipse XDB-C18column with mobile phase consisted of water-acetonitrile-ethanol(gradient elution)at the flow rate of 1.0 mL/min. The column temperature was 35 ℃,and the detection wavelength was set at 230 nm. The sample size was 20 μ L. Established method was used to determine related substances in 3 batches of Cabazitaxel injection.RESULTS:
The linear relationship of cabazitaxel were 0.039-11.60 μ g/mL(r=0.999 8,n=7). The detection limit was 2×10-4μg,and quantitation limit was 8×10-4μg. RSD of precision and reproducibility tests were all lower than 10.0%(n=6). The amount of single impurity in 3 batches of samples ranged 0.07%-0.08%,and total amount of impurities were 0.26%-0.29%.CONCLUSIONS:
Established method is simple,accurate and reliable,can be used for the determination of related substances in Cabazitaxel injection.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
China Pharmacy
Year:
2018
Type:
Article
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