HPLC法同时测定复方奥硝唑贴膜中奥硝唑和地塞米松磷酸钠的含量

Simultaneous Determination of Ornidazole and Dexamethasone Sodium Phosphate in Compound Ornidazole Film by HPLC

目的：建立同时测定复方奥硝唑贴膜中奥硝唑和地塞米松磷酸钠含量的方法。方法：采用高效液相色谱法。色谱柱为Inertsil ODS-3,流动相为甲醇-20 mmol/L磷酸盐缓冲液（用冰乙酸调p H至7.40）（55∶45,V/V）,流速为1.0 ml/min,柱温为30℃,检测波长为242 nm,进样量为10μl。结果：奥硝唑、地塞米松磷酸钠检测质量浓度线性范围均为1～100μg/ml（r=0.999 7、0.999 9）;精密度、稳定性、重复性试验的RSD〈2.0%;加样回收率分别为96.50%～99.80%、96.50%～99.60%,RSD分别为1.02%、0.99%（n=9）。结论：该方法专属性强、精密度和稳定性好、准确度高,可同时测定复方奥硝唑贴膜中奥硝唑和地塞米松磷酸钠的含量。

OBJECTIVE：To establish a method for the simultaneous determination of ornidazole and dexamethasone sodium phosphate in Compound ornidazole film. METHODS：HPLC was performed on the column of Inertsil ODS-3 with mobile phase of methanol-20 mmol/L phosphate buffer（p H was adjusted to 7.40 with glacial acetic acid）（55∶45,V/V） at a flow rate of 1.0 ml/min,column temperature was 30 ℃,detection wavelength was 242 nm and volume injection was 10 μl. RESULTS：The linear range were 1-100 μg/ml for both ornidazole（r=0.999 7）and dexamethasone sodium phosphate（r=0.999 9）;RSDs of precision,stability and reproducibility tests were lower than 2.0%;recoveries were 96.50%-99.80%（RSD=1.02%,n=9）and 96.50%-99.60%（RSD=0.99%,n=9）. CONCLUSIONS：The method is specific with good precision and stability and high accuracy,and can be used for the simultaneous determination of ornidazole and dexamethasone sodium phosphate in Compound ornidazole film.