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

✍ Scribed by Kennedy O. Abuga; Hezekiah K. Chepkwony; Eugene Roets; Jos Hoogmartens

Publisher
John Wiley and Sons
Year
2001
Tongue
English
Weight
137 KB
Volume
24
Category
Article
ISSN
1615-9306

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✦ Synopsis

A stability-indicating HPLC method for the separation of clarithromycin and related substances in bulk samples 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 lm, 25064.6 mm column thermostated at 568C. 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.

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