LC determination of impurities in azithromycin tablets

J Pharm Biomed Anal. 2003 Sep 19;33(2):211-7. doi: 10.1016/s0731-7085(03)00258-9.


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 microm 250 x 460 mm kept at 50 degrees C. Six impurities were separated and identified and it was possible to quantify five out of the six with reasonable accuracy and precision.

MeSH terms

  • Acids
  • Anti-Bacterial Agents / analysis*
  • Azithromycin / analysis*
  • Chromatography, High Pressure Liquid
  • Drug Stability
  • Hot Temperature
  • Light
  • Oxidants / chemistry
  • Reference Standards
  • Reproducibility of Results
  • Spectrophotometry, Ultraviolet
  • Tablets


  • Acids
  • Anti-Bacterial Agents
  • Oxidants
  • Tablets
  • Azithromycin