LC determination of impurities in azithromycin tablets

Abstract

A LC method with UV detection for determining azithromycin impurities in tablets as pharmaceutical form has been developed. It is to be employed in routine and stability tests. A linear gradient elution was employed starting with 47% A and 53% B to reach 28% A and 72% B at 48 min. Mobile phase A was KH2PO4 10 mM (H2O) at pH 7.00. B was a mixture methanol:acetonitrile 1:1 (v/v). UV detection was performed at 210 nm. The chromatographic column was Phenomenex Synergi† MAX-RP 4 mm 250 /460 mm kept at 50 8C. Six impurities were separated and identified and it was possible to quantify five out of the six with reasonable accuracy and precision.