STABILITY-INDICATING ASSAY FOR AZATHIOPRINE AND 6-MERCAPTOPURINE BY REVERSED-PHASE HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY

被引:21
作者
FELL, AF [1 ]
PLAG, SM [1 ]
NEIL, JM [1 ]
机构
[1] WESTERN GEN HOSP, DEPT PHARM, EDINBURGH EH4 2XU, MIDLOTHIAN, SCOTLAND
来源
JOURNAL OF CHROMATOGRAPHY | 1979年 / 186卷 / DEC期
关键词
D O I
10.1016/S0021-9673(00)95289-0
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
A rapid method based on reversed-phase high-performance liquid chromatography is described for the separation and quantitation of azathioprine, 6-mercaptopurine and their potential contaminants and degradants present in dosage forms. Procedures based on simple dissolution or extraction in 0.02 M NaOH give quantitative precision of 1 % relative standard deviation at the macro-level and 2 % relative standard deviation for the micro-assay of analytes. The method is stability-indicating and has been used for preliminary studies of the degradation of azathiorine in 0.9 % sodium chloride injection, subjected to thermal or ultraviolet irradiation treatment. The content uniformity of dosage forms of azathioprine and 6-mercaptopurine has been measured Only azathioprine injection as the freeze-dried sodium salt ws found to contain detectable amounts of contaminants 6-mercaptopurine, 1-methyl-4-nitro-5-chloroimidazole and hypoxanthine. © 1979.
引用
收藏
页码:691 / 704
页数:14
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