Simultaneous Content Determination of Gatifloxacin Dexamethasone Acetate Ear Drops by HPLC / 中国药师

ABSTRACT

Objective:To developed an HPLC method for the simultaneous content determination of gatifloxacin dexamethasone ac-etate ear drops. Methods:The promising chromatographic separation was achieved on a Phenomenex C18 (250 mm × 4. 6 mm, 5 μm) column. Using gradient elution method, the optimized mobile phase consisted of methanol as the solvent A, and 0. 05% triethylamine solution (adjusting pH to 3. 0 with acetic acid) as the solvent B. The flow rate was 1. 0 ml·min-1, the column temperature was 30℃and the UV detection was carried out at 240 nm. Results: The compounds were separated well, the linearity between the peak areas and the concentrations was observed within the range of 1. 2-60. 0 mg·L-1 for gatifloxacin, and 0. 8-40. 0 mg·L-1 for dexamethasone acetate. The mean recovery of gatifloxacin and dexamethasone acetate was 101. 31% ( RSD =1. 17%) and 99. 71% ( RSD =1. 01%) , respectively. Conclusion: The method is specific and stable in the determination of gatifloxacin dexamethasone acetate ear drops.