高效液相色谱法同时测定呋麻滴鼻液中盐酸麻黄碱和呋喃西林含量

Determination of ephedrine hydrochloride and nitrofurazone in compound nitrofurazone nasal drops by HPLC

目的建立HPLC法测定呋麻滴鼻液中呋喃西林和盐酸麻黄碱的含量。方法色谱柱:Dubhe C_(18)(4.6 mm×250 mm,5μm);流动相:以磷酸盐缓冲液(取磷酸二氢钾6.8 g,三乙胺5 mL,磷酸4 mL,加水至1000 mL,用稀磷酸或三乙胺调节pH值至3.0±0.1)为流动相A,以乙腈为流动相B,梯度洗脱;检测波长为260 nm;流速:1.0 mL·min^(-1)。结果盐酸麻黄碱、呋喃西林分别在400.25~2401.49μg·mL^(-1)和8.47~50.83μg·mL^(-1)(n=6)与峰面积呈良好的线性关系;低、中、高组盐酸麻黄碱的平均回收率分别为99.4%、99.0%和99.9%,RSD分别为0.88%、0.41%和0.020%(n=3);低、中、高组呋喃西林的平均回收率分别为98.0%、97.8%和98.3%,RSD分别为0.91%、0.77%和0.26%(n=3)。结论该方法简便、准确,重复性好,可用于该制剂的质量控制。

Objective To determine the content of nitrofurazone and ephedrine hydrochloride in compound nitrofurazone nasal drops by HPLC. Methods An HPLC method was performed on a column ofDubhe C18 （4.6 mm × 250 mm, 5 μm） at a UV detection wavelength of 260 nm. The mobile phase consisted of acetonitrile and phosphate buffer was used as the gradient elution for separation, with the flow rate at 1.0 mL · min - 1. Results A good linear relationship was established between the peak response and the concentration of ephedrine hydrochloride and nitrofurazone at 400.25 - 2401.49 and 8.47 - 50.83μg · mL - 1 （n = 6）, respectively. The average recovery of ephedrine hydrochloride in the low, medium and high group was 99.4%, 99.0% and 99.9%, RSD = 0.88%, 0.41% and 0.020%, respectively, （n = 3）. The average recovery of nitrofurazone in the low, medium and high group was 98.0%, 97.8% and 98.3%, RSD = 0.91%, 0.77% and 0.26%, respectively （n = 3）. Conclusion This method is simple and accurate, and can be used in the quality control of compound nitrofurazone nasal drops.