高效液相色谱法测定复方氟麻滴鼻液3组分含量

Determination of Ephedrine Hydrochloride,Ofloxacin and Dexamethasone Phosphate Contents in Compound Ofloxacin Ephedrine Nasal Drops by HPLC

目的：建立测定复方氟麻滴鼻液中盐酸麻黄碱、氧氟沙星、地塞米松磷酸酯含量的高效液相色谱法。方法色谱柱为Sbim－pack C18柱（250 mm ＆#215;4.6 mm，5μm），流动相为甲醇－10 g／L乙酸铵溶液（磷酸调节pH至6.0，52：48），流速为1.0 mL／min，检测波长为256 nm，柱温为30℃，进样量为10μL。结果该方法不受处方中辅料的干扰；盐酸麻黄碱、氧氟沙星、地塞米松磷酸酯的进样量线性范围分别为0.3632~10.8960μg（ r=0.9996，n=9），0.2690~8.0708μg（ r=0.9995，n=9），0.0465~1.3956μg（ r=0.9999， n=9），平均回收率分别为98.80%，99.28%，99.36%，RSD分别为1.82%，2.14%，1.18%（ n=9）。结论该方法操作简便、灵敏度高、重复性好，可用于复方氟麻滴鼻液中盐酸麻黄碱、氧氟沙星、地塞米松磷酸酯的含量测定。

Objective To establisb an HPLC metbod for determining tbe epbedrine bydrocbloride,ofloxacin and dexametbasone pbospbate contents in Compound Ofloxacin Epbedrine Nasal Drops. Methods Tbe cbromatograpbic column was Sbim-pack C18 column（250 mm ＆#215; 4. 6 mm,5 μm）,tbe mobile pbase was composed of metbanol-10 g/L ammonium acetate（adjusting to pH 6. 0 witb pbospboric acid, 52 ：48）;tbe flow rate was 1. 0 mL/min;tbe detection wavelengtb was 256 nm;tbe column temperature was 30 ℃ and tbe injection volume was 10 μL. Results Tbis metbod was not interfered by tbe auxiliary materials in prescription. Tbe linear ranges of epbedrine bydrocbloride,ofloxacin and dexametbasone pbospbate were 0. 363 2-10. 896 0 μg（ r=0. 999 6,n=9）,0. 269 0-8. 070 8 μg （ r=0. 999 5,n=9）and 0. 046 5-1. 395 6 μg（ r=0. 999 9,n=9）respectively,tbeir average recovery rates were 98. 80%,99. 28% and 99. 36%,RSD were 1. 82%,2. 14% and 1. 18%（ n=9）respectively. Conclusion Tbe metbod is simple and accurate witb bigb sensi-tivity and good repeatability,and can be used for tbe determination of epbedrine bydrocbloride,ofloxacin and dexametbasone pbospbate contents in Compound Ofloxacin Epbedrine Nasal Drops.