Determination of Miconazole Nitrate in Compound Dexamethasone Acetate Salicylate Tincture by HPLC

OBJECTIVE To establish an HPLC method to determine miconazole nitrate in compound dexamethasone acetate salicylate tincture. METHODS The analysis was carried out at 35 ℃ on a Hypersil C₁₈ column (250 mm×4.6 mm, 5 mm). The mobile phase consisted of acetonitrile-methanol-0.5% ammonium acetate solution (40∶40∶15) with the flow rate of 1.0 mL·min^-1. The detection wavelength was 220 nm. The column temperature was 35 ℃. RESULTS The calibration curve of miconazole nitrate was linear over the range of 30.72-81.92 μg·mL^-1(r=0.999 7). The average recovery was 99.6% (RSD=0.68%, n=9). CONCLUSION This method is simple, accurate, reproducible and applicable for the content determination of miconazole nitrate in compound dexamethasone acetate salicylate tincture.