IMPURITY PROFILING OF CLARITHROMYCIN USING HIGH-PERFORMANCE LIQUID-CHROMATOGRAPHY WITH ULTRAVIOLET DETECTION

被引:13
作者
MORGAN, D
CUGIER, P
MARELLO, B
SAROCKA, C
STROZ, D
PLASZ, A
机构
[1] Analytical Research Department, Abbott Laboratories, Department 417 R1B, North Chicago
来源
JOURNAL OF CHROMATOGRAPHY | 1990年 / 502卷 / 02期
关键词
D O I
10.1016/S0021-9673(01)89599-6
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
Clarithromycin is a semi-synthetic antibiotic. High-performance liquid chromatography is used to identify and estimate both manufacturing and degradation impurities. The sample is chromatographed on a YMCC18 column using an eluent of acetonitrile-0.033 M KH2PO4 (48:52) at an apparent pH of 5.4 and ultraviolet detection at 205 nm. Due to the limited availability of impurities, all related substances are referenced to a single impurity standard. A computing integrator is programmed to compensate for differences in detector responses and to identify and calculate the % (w/w) of all known impurities. The majority of all currently identified impurities are detectable at the 0.10% (w/w) level. © 1990.
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页码:351 / 358
页数:8
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