高效液相色谱法测定氯麻滴鼻液中氯霉素和盐酸麻黄碱的含量

Determination of chloramphenicol and ephedrine hydrochloride in nasal drops by HPLC

目的 :建立测定氯麻滴鼻液中氯霉素和盐酸麻黄碱含量的高效液相色谱法。方法 :采用反相 μ Bondpak色谱柱 ,甲醇- 0 .0 2mol·L-1磷酸二氢钾 (5 5∶45 ,磷酸调 pH值3.5 )为流动相 ,检测波长 2 5 4nm。结果 :氯霉素和盐酸麻黄碱的线性范围分别为 2 0～ 12 0 μg·ml-1(r =0 .9998) ,80～ 480 μg·ml-1(r =0 .9998) ;加样回收率分别为 10 1.4% ,RSD =0 .5 %及 10 0 .8% ,RSD =0 .9% (n =5 ) ,日内RSD分别为 0 .9%和 0 .4% (n =5 ) ,日间RSD分别为 1.0 %和 0 .8% (n =4)。结论 :HPLC法可用于本制剂的含量测定和质量控制 ,方法简便、灵敏。

OBJECTIVE To establish an HPLC method for determination of chloramphenicol and ephedrine hydrochloride in its nasal drops.METHODS μ-Bondpak C 18 column was used as stationary phase and methanol- 0.02 mol·L -1 KH 2PO 4(55∶45, adjust pH to 3.5 with H 3PO 4 ) as mobile phase, the detection wavelength was 254 nm . RESULTS The linear ranges of chloramphenicol and ephedrine hydrochloridum were 20 ～ 120 μg·ml -1(r= 0.9998) and 80 ～ 480 μg·ml -1(r= 0.9998), respectively; the average recovery was 101.4%(RSD= 0.5%)and 100.8%(RSD= 0.9, n=5 );the RSD of intra-day was 0.9% and 0.4%(n=5). The RSD of inter-day 1.0% and 0.8%( n=4 ). CONCLUSIONS This method was found to be simple,accurate ,sensitive,and can be used for the quality control.