高效液相色谱法测定氨麻美敏片3个组分含量方法的改进

目的 建立测定氨麻美敏片中盐酸伪麻黄碱、氢溴酸右美沙芬、马来酸氯苯那敏含量的高效液相色谱法.方法 采用Waters Xterra RP18柱(250mm×4.6 mm,5μm),流动相为乙腈-水-三乙胺(17:81.5:1.5),流速为1.0mL/min,检测波长210nm,柱温35℃.结果 盐酸伪麻黄碱、氢溴酸右美沙芬、马来酸氯苯那敏质量浓度分别在150～360μg/mL(r=0.9999),80～190 μg/mL(r=1.0000),1O～24μg/mL(r=1.0000)范围内与峰面积呈良好的线性关系,平均回收率分别为99.89%,99.92%,99.91%,RSD分别为0.73%,0.34%,0.35%(n=9),检测限分别为0.69,0.75,1.48 μg/mL.结论 该方法准确、简便,可用于氨麻美敏片中3个组分的的含量测定.

Improvement of HPLC Method for Determination of Three Components in Pseudoephedrine Hydrochloride,Dextromethorphan Hydrobromide and Chlorphenamine Maleate Tablets

Objective To establish an HPLC method to determine the content of pseudoephedrine hydrochloride, dextromethorphan hydro- bromide,chlorphenamine maleate in tablet. Methods A Waters Xterra RP18 column （250 mm ×4. 6 mm,5 μm） is used,mobile phase is acetonitrile- water-triethylamine （17：81.5：1.5）,flow rate is 1.0 mL/min,detection wavelength is 210 nm and column temperature is 35 ℃. Results A good linearity was observed between each component and corresponding peak area for pseudoephedrine hydrochloride, dextromethorphan hydrobromide and chlorphenamine maleate in the range of 150-360μg/mL （r=0. 9999）,0- 190 μg/mL（ r=1. 000 0）, 10- 24 μg/mL（ r = 1. 000 0） respectively,the average recovery rate was 99.89% ,99.92% and 99.91% ,the RSD was 0.73% ,0. 34% and 0. 35% （n =9）and the LOD was 0. 69,0.75,1.48 μg/mL. Conclusion This analytical method is accurate and facilitative and is suitable for intended use.