A Study on the Determination of Azithromycin by High-Performance Liquid Chromatography

Abstract

Objective: To analyze the effect of high-performance liquid chromatography (HPLC) for the determination of azithromycin and to provide references for related research work. Methods: The mobile phase was ammonium dihydrogen phosphate at 0.067 mol/L (mixed with triethylamine; pH value was adjusted to 6.5). The chromatographic column was Kromasil C18 (250 mm × 4.6 mm; 5.0 ?m) and the relative standard deviation (RSD) of the drug content level was 1.25%. The injection volume was set to 20 ?L, the detection wavelength was set to 210 nm, the external standard method was used to complete the quantitative work, and the theoretical plate number should be more than 1000 according to the drug peak calculation. The effect of HPLC on the determination of azithromycin was analyzed. Results: The concentration of azithromycin was 1.40-3.40 mg/mL, and the linear relationship was good. RSD of the drug content level was 1.25%. The representative test product had strong stability within 8.0 hours and the method had good repeatability. According to the recovery experiment method, the recovery rates of three standard samples from low to high were 99.87%, 100.15%, and 100.62%. The average recovery rate was 100.21%. RSD value was 0.39%. It means that the recovery rate of HPLC is good. Conclusion: In the determination of azithromycin, the use of HPLC to complete the work was of high sensitivity, simple, and fast. The method had good repeatability in the determination of drug components which is worthy of further promotion.