高效液相色谱法测定复方氯麻滴鼻液中三组分的含量

Determination of 3 components of compound chloramphenicol and ephedrine hydrochloride nasal drops by HPLC

目的建立高效液相色谱法测定复方氯麻滴鼻液含量的方法.方法采用反相高效液相色谱法,以C18为固定相,甲醇-0.1mol·L-1醋酸铵溶液(磷酸调pH 4.0)(50:50)为流动相,检测波长256nm.结果氯霉素、盐酸麻黄碱和地塞米松磷酸钠的线性范围分别为:12.5～125μg·mL-1(r=0.999 4),50～500μg·mL-1(r=0.9991)、2.5～25μg·mL-1(r=0.9990).平均加样回收率分别为99.9%(RSD=1.5%)、100.3%(RSD=0.7%),98.7%(RSD=0.9%).结论该方法简便、准确,适用于复方氯麻滴鼻液的质量控制.

OBJECTIVE To establish a method for dete rm ining the content of chloramphenicol, ephedrine hydrochloride and dexamethasone sodium phosphate in its nasal drops by HPLC.METHOD A Hypersil ODS C 18 column was used as stationary p hase and methanol-0.1mol·L -1 ammonium acetate solution (adjusted pH to 4 .0 with phosphoric acid)(50∶50) as mobile phase, the detective wavelength was 2 56nm.RESULTS The linear ranges of chloramphenicol, ephedrine hydroch loride and dexamethasone sodium phosphate were 12.5~125μg·mL -1(r=0.9 994), 50~500μg·mL -1(r=0.9991) and 2.5~25μg·mL -1(r=0.9990 ),respectively. The average recoveries were 99.9%(RSD=1.5%),100.3%(RSD=0.7% ) and 98.7%(RSD=0.9%). CONCLUSION This method is found to be simple, accurate, and be suitable for the quality control of the preparation.