Abstract
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 YMCC 18 column using an eluent of acetonitrile—0.033 M KH 2PO 4 (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.
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