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Okaru AO, Abuga KO, Kamau FN, Ndwigah SN, Lachenmeier DW. "A Robust Liquid Chromatographic Method for Confirmation of Drug Stability of Azithromycin in Bulk Samples, Tablets and Suspensions." Pharmaceutics. 2017;9(1):11. Abstract

A simple, isocratic and robust RP-HPLC method for the analysis of azithromycin was
developed, validated and applied for the analysis of bulk samples, tablets and suspensions. The
optimum chromatographic conditions for separation were established as a mobile phase comprised
of acetonitrile-0.1 M KH2PO4 pH 6.5-0.1 M tetrabutyl ammonium hydroxide pH 6.5-water (25:15:1:59
v/v/v/v) delivered at a flow rate of 1.0 mL/min. The stationary phase consisted of reverse-phase
XTerra® (250 mm × 4.6 mm i.d., 5 μm particle size) maintained at a temperature of 43 °C with a UV detection at 215 nm. The method was found to be linear in the range 50%–150% (r2 = 0.997). The limits of detection and quantification were found to be 0.02% (20 μg) and 0.078% (78 μg), respectively, with a 100.7% recovery of azithromycin. Degradation products of azithromycin in acidic and oxidative environments at 37 °C were resolved from the active pharmaceutical ingredient and thus the method is fit for the purpose of drug stability confirmation.

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