反相高效液相色谱法同时测定复方呋喃西林滴鼻剂中两组分含量

Determination of Contents in Compound Furacilin Nasal Drops by RP - HPLC

目的:用反相高效液相色谱法(RP-HPLC法)测定复方呋喃西林滴鼻剂中呋喃西林和盐酸麻黄碱的含量。方法:采用XDB-CR色谱柱,以含0.2%三乙胺、用磷酸调节pH=3.00的0.02 mol/L磷酸二氢钾溶液-甲醇(80:20)为流动相,流速为1.0 mL/min,柱温为30℃, 检测波长为254nm,内标物为氧氟沙星。结果:呋喃西林的线性范围为0.02-0.10mg/mL(r=0.999 9),平均回收率为99.05%,RSD= 0.67%(n=3);盐酸麻黄碱的线性范围为1.00-5.00mg/mL(r=0.999 9),平均回收率为99.46%,RSD=0.34%(n=3)。结论:RP-HPLC 法操作简便,测定结果准确,回收率稳定,可用于复方呋喃西林滴鼻荆的质量控制。

Objective： To establish a RP- HPLC method for determination of furacilin and ephedrine hydrochloride in compound furacilin nasal drops. Methods： The analysis was carried on a XDB-Cs column. The mobile phase consist of methanol-0.02 mol/L pottassium dihydrogen phosphate solutions （containing 0.2% triethylamine and pH adjusted to 3 with phosphate acid）（20：80） and the flow rate was 1.01 mL/min,the detection wavelength was at 254 nm and the column temperature was 30℃ .Ofloxacin was used as the internal substance. Results： The linear range was 0. 02 - 0. 10 mg/mL（ r = 0. 999 9） for furacilin, 1.00 - 5. 00 mg/mL（ r =0. 999 9） for ephedrine hydrochloride. The average recoveries were 99.05% （ RSD = 0. 67% , n = 3） for furacilin, 99.46% （ RSD = 0. 34% , n = 3） for ephedrine hydrochloride. Conclusion： The method is reliable, accurate and suitable for simultaneous determination of furacilin and ephedrine hydrochloride in compound furacilin nasal drops.