Objective  To establish an HPLC method for the rapid determination of the dissolution of cefixime granules, and to evaluate the similarity of the in vitro dissolution curves of the self-developed preparation and the reference listed drug.

Methods  The HPLC method was used, the chromatographic column was Thermo Accucore C₁₈ (50 mm×4.6 mm, 2.6 μm) column, the mobile phase was 0.8% trifluoroacetic acid aqueous solution and acetonitrile (80∶20), the flow rate was 1.2 mL·min^-1, the detection wavelength was 254 nm, the column temperature was 45℃, and the injection volume was 5 μL. The dissolution curves of cefixime granules from the self-developed preparation and the reference listed drug in four dissolution media (water, pH 1.2 hydrochloric acid solution, pH 6.8 phosphate buffer and pH 7.5 phosphate buffer) were determined.

Results  The methodological results were consistent with the detection requirements. Cefixime revealed a good linear relationship within the range of 10.05-251.30 μg·mL^-1, and the mean recoveries in the four dissolution media were 99.3%, 99.1%, 100.2% and 99.8% with RSDs of 0.79%, 0.74%, 0.48% and 0.45% (n=9), respectively. The similarity factors of the self-developed preparation and the reference listed drug in water and pH 1.2 hydrochloric acid solution were 57 and 55, respectively, and the dissolution in pH 6.8 phosphate buffer and pH 7.5 phosphate buffer at 15 min were both greater than 85%.

Conclusion  The method is rapid and accurate, and can be used for the determination of dissolution of cefixime granules to provide a reference for consistency evaluation of in vitro dissolution curves of cefixime granules.

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