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Development and validation of rapid HPLC method for quantifying macrolide antibiotics azithromycin (AZI) and spiramycin (SPI) in bulk and tablet samples is described. Determination was performed on a reversed phase C 18 ODB column (250×4.6 nm I.D) at ambient temperature, and employing a UV-detection set at 210 nm. The mobile phase consists of acetonitrile -2-methyl-2-propanol-hydrogenphosphate buffer, pH 6.2, with 1.8% triethylamine (32:8: up to 100, v/v/v), delivered at a flow-rate of 1.1 mL min -1 . The assay is linear in concentration ranges of: 0.004-4.8 and 0.0003-1.2 mg mL −1 for azithromycin and spiramycin, respectively, with detection limit of 0.02% for SPI and 0.03% for AZI. Recovery experiments revealed recovery of 98.51- 100.82%. The applicability of this method in stability assessment studies is evaluated.

LC Determination and Stability Assessment of Macrolide Antibiotics Azithromycin and Spiramycin in Bulk and Tablet Samples