A simple, isocratic and robust RP-HPLC method for the analysis of azithromycin was\ndeveloped, validated and applied for the analysis of bulk samples, tablets and suspensions.\nThe optimum chromatographic conditions for separation were established as a mobile phase\ncomprised of acetonitrile-0.1 M KH2PO4 pH 6.5ââ?¬â??0.1 M tetrabutyl ammonium hydroxide pH 6.5-water\n(25:15:1:59 v/v/v/v) delivered at a flow rate of 1.0 mL/min. The stationary phase consisted of\nreverse-phase XTerraÃ?® (250 mm Ã?â?? 4.6 mm i.d., 5 Ã?¼m particle size) maintained at a temperature of\n43 ââ??¦C with a UV detection at 215 nm. The method was found to be linear in the range 50%ââ?¬â??150%\n(r2 = 0.997). The limits of detection and quantification were found to be 0.02% (20 Ã?¼g) and 0.078%\n(78 Ã?¼g), respectively, with a 100.7% recovery of azithromycin. Degradation products of azithromycin\nin acidic and oxidative environments at 37 ââ??¦C were resolved from the active pharmaceutical ingredient\nand thus the method is fit for the purpose of drug stability confirmation.
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