Abstract
AbstractA simple, robust, sensitive, and selective liquid chromatography method suitable for the determination of the semi‐synthetic antibiotic, josamycin propionate, and related substances is described. This method utilizes XTerra RP18 5 μm (25 cm×4.6 mm ID) as a stationary phase at 30°C and acetonitrile – 0.2 M ammonium acetate (pH 6.0) – water (51 : 3 : 46, v/v/v) as a mobile phase, delivered at 1.0 mL/min. UV detection is performed at 232 nm. Josamycin propionate is completely separated from the seven related substances of known identity and from at least seven unknown impurities, present in commercial samples. The robustness of the method was evaluated by a full‐factorial experimental design. The LOQ for josamycin propionate was 0.03% and the LOD was 0.01%. For most samples the analysis time is 90 min. Exceptionally, very strongly retained impurities may require an isocratic analysis time of 160 min. In that case, time can be saved by using gradient elution, which needs an analysis time of almost 100 min.
Published Version
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