HPLC法测定复方酮替芬滴鼻液中3组分的含量

Content Determination of Three Main Drugs in Compound Ketotifen Fumarate Nasal Drops by HPLC

目的:测定复方酮替芬滴鼻剂中主要成分的含量。方法:采用HPLC法,色谱柱Diamonsil C18柱(4.6mm×150mm,5μm);流动相为乙腈-1%乙酸胺溶液(pH5.5)=10∶90;流速为1mL·min-1;检测波长为240nm;柱温为室温。结果:富马酸酮替芬在40.0～160.0μg·mL-1的范围内,其浓度与峰面积呈良好的线性关系,得回归方程A=1.178C-5.193,r=0.9995(n=7),平均回收率为100.61%,RSD=0.49%(n=5)。盐酸麻黄碱在200.0～800.0μg·mL-1的范围内,其浓度与峰面积呈良好的线性关系,得回归方程A=0.3680C-6.455,r=0.9993(n=7),平均回收率为99.99%,RSD=0.38%(n=5)。呋喃西林在8.0～30.0μg·mL-1的范围内,其浓度与峰面积呈良好的线性关系,得回归方程A=66.58x-4.103,C=0.9998(n=7),呋喃西林的平均回收率为98.69%,RSD=0.92%(n=5)。结论:本方法建立的高效液相色谱法操作简单,准确、专属性强、重现性好,可作为复方酮替芬滴鼻剂中酮替芬、麻黄碱、呋喃西林的含量测定。

Objective： To determine the contents of main drugs in compound ketotifen fumarate nasal drops. Methods： An HPLC method was employed with the chromatographic column as Diamonsil C18 （4.6mm×150mm, 5μm, room temperature）. The mobile phase was acetonitrile： ammonium acetate（pH 5.5）= 10：90. The flow rate was 1.0 mL·min^-1. The detection wavelength was 240 nm. Results： Ketotifen fumarate has a good linearity over the range of 40.0-160.0 μg·mL^-1, with the regression equation of A=1.178C-5.193, r=0.9995（n=7）. The average recovery rate was 100.61%, RSD was 0.49%（n=5）. Ephedrine hydrochloride has a good linearity at the range of 200.0-800.0 μg·mL^-1, with the regression equation of A=0.3680C-6.455, r= 0.9993 （n=7）. The average recovery rate was 99.99%, RSD was 0.38%（n=5）. Nitrofurazone has a good linearity over the range of 8.0-30.0 μg·mL^-1, with the regression equation of A=66.58C-4.103, r=0.99987 （n=7）. The average recovery rate was 98.69%, RSD was 0.92%（n=5）. Conclusion： The proposed method is simple, specific, and can be used in the content determination of ketotifen fumarate, ephedrine hydrochloride and nitrofurazone in compound Ketotifen fumarate nasal drops.