Analysis of ganciclovir and its related substances using high performance liquid chromatography and liquid chromatography-mass spectrometry methods / 西安交通大学学报·英文版
Academic Journal of Xi'
;
an Jiaotong University;(4): 218-222, 2010.
Article
in Chinese
| WPRIM
| ID: wpr-844703
ABSTRACT
Objective:
High performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC/MS) methods were developed for the determination of ganciclovir and its related substances.Methods:
A Hypersil ODS2 column (4.6 mm x 250 mm, 5 μm) was used with a mobile phase of 0.02 M potassium dihydrogen phosphate buffer (pH 6.0)-methanol (928) at a flow rate of 1.0 mL/min, and UV detector set at 254 nm was used for monitoring the eluents.Results:
The method was simple, rapid, selective and capable of separating all related substances at trace level with a detection limit of 0.04 μg/mL. It has been validated with respect to accuracy, precision, linearity, and limits of detection and quantification. The linearity range was 10.2-153.0 μg/mL with r = 0.9998. The percentage recoveries ranged from 96.7% to 101.6%, and RSD was 1.24%-1.96% (n = 5).Conclusion:
The method was found to be suitable not only for monitoring the reactions during the process development but also for quality control of ganciclovir. For identification of related substances, LC/MS was used. The mainly related substances of ganciclovir active pharmaceutical ingredients (API) were determined as guanine, (1, 3-dioxolan-4-yl) methyl acetate, and diacetyl guanine.
Full text:
Available
Index:
WPRIM (Western Pacific)
Language:
Chinese
Journal:
Academic Journal of Xi'an Jiaotong University
Year:
2010
Type:
Article
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