A stability-indicating HPLC method for the separation of clarithromycin and related substances in bulk samples

被引：0
|
作者：
Abuga, KO [1 ]
Chepkwony, HK [1 ]
Roets, E [1 ]
Hoogmartens, J [1 ]
机构：
[1] Catholic Univ Louvain, Fac Farmaceut Wetenschappen, Lab Farmaceut Chem Analyse van Geneesmiddelen, B-3000 Louvain, Belgium
来源：
JOURNAL OF SEPARATION SCIENCE | 2001年 / 24卷 / 10-11期
关键词：
liquid chromatography; clarithromycin; XTerra RP18;
D O I：
10.1002/1615-9314(20011101)24:10/11<849::AID-JSSC849>3.0.CO;2-M
中图分类号：
O65 [分析化学];
学科分类号：
070302 ; 081704 ;
摘要：
Clarithromycin is a 6-O-methylated semi-synthetic derivative of erythromycin A, which is more resistant towards acid decomposition. Commercial clarithromycin samples contain several potential impurities arising from the manufacturing process and degradation. A simple, selective, and sensitive isocratic liquid chromatographic method has been developed for the impurity profiling of clarithromycin bulk samples. The method employs a XTerra RP18, 5 mum, 250 x 4.6 mm column thermostated at 56 degreesC. The mobile phase consists of acetonitrile - 0.2 M potassium phosphate buffer pH 6.80 - water (40:3.5:56.5). Several peaks are of unknown identity. The method is stability indicating.
引用
收藏
页码：849 / 855
页数：7
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