Determination of Related Substances in Vidarabine Monophosphate for Injection by HPLC
- VernacularTitle:HPLC法测定注射用单磷酸阿糖腺苷中的有关物质
- Author:
Xuwen JIAO
;
Weiyang LIANG
- Publication Type:Journal Article
- Keywords:
Vidarabine monophosphate for injection;
Related substances;
Vidarabine;
Adenine;
HPLC;
Impurity assay
- From:
China Pharmacist
2015;(4):652-655
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an HPLC method for the determination of the related substances in vidarabine monophosphate for injection. Methods:The known impurities vidarabine and adenine in vidarabine monophosphate for injection were analyzed by an external standard method on a Kromasil 100-5 C18 column(250 mm × 4. 6 mm,5μm)with the mobile phase consisting of water(contai-ning 10 mmol·L-1 tetrabutyl ammonium hydroxide and 10 mmol·L-1 potassium dihydrogen phosphate)-methanol(80:20)at a flow rate of 1. 0 ml·min-1,the detection wavelength was set at 258nm,the column temperature was at 30℃,and the sample size was 20μl. Meanwhile,the unknown impurities were examined by a self-control method. Results:Good linear relationships of vidarabine and adenine were obtained within the range of 0.0765 ~1.530 7μg·ml-1(r =0.999 9)and 0.078 0 ~1.560 0 μg·ml-1(r =0. 999 9). The corresponding average recovery was 99. 8% with RSD of 0. 2%(n=9)for vidarabine and 97. 0% with RSD of 1. 2%(n=9)for adenine. Conclusion:The method can be used to determine the related substances in vidarabine monophosphate for injec-tion.
