Development of Rapid, Simple and Stability-Indicating Method for Determination of Azithromycin Using RP-HPLC

An accurate, sensitive, precise and stability indicating (in accordance with ICH guidelines) reversed phase high performance liquid chromatographic (RP-HPLC) method of analysis of Azithromycin was developed and validated. The chromatographic conditions comprised of a reversible phase C8 column (250 × 4.6 mm, 5μ) with a mobile phase consisting of a mixture of dipotassium hydrogen Phosphate and Acetonitrile in the ratio of 65:35 at pH 6.5 adjusted with phosphoric acid. Flow rate was 1.5 ml/min, the detection was carried out at 200 nm and the retention time of Azithromycin was 2.99 min. Azithromycin was subjected to acid and alkali hydrolysis, oxidation and photochemical degradation. The method was validated for accuracy, precision and robustness. The results indicate that the drugs are susceptible to degradation in different conditions. All the peaks of degraded products were resolved from the active pharmaceutical ingredient with significant different retention times. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating one.