【摘要】 目的:建立了愈美甲麻敏分散片中4种有效成分及杂质的含量测定方法。方法:采用高效液相色谱/二极管阵列检测器法,色谱柱为 ODS 柱(Shimadzu CLC-ODS 150mm×6.0mm,5μm),流动相为0.1%磷酸(含0.34%磷酸二氢钾)-甲醇(65:35),流速1mL·min(-1),检测波长205nm。结果:氢溴酸右美沙芬、愈创甘油醚、马来酸氯苯那敏、甲基麻黄碱分别在6～30,20～100,0.6～3,4～20μg·mL(-1)范围内,线性关系良好,平均回收率分别为103.3%,98.6%,95.8%,98.5%。3批样品未知物总含量均小于0.6%;未知物中单一未知物最高含量小于0.2%。结论:本方法快捷,提供的信息量大,采用的色谱条件可满足愈美甲麻敏分散片中4种有效成分及杂质的含量测定。更多还原

【Abstract】 To establish a method for determination of four active ingrediants and impurities in Yumei- jiamamin dispersible tablets by HPLC.Method:Adopting efficient liquid chromatograph,the procedure performed u- sing a stainless steel column（Shimadzu CLC-ODS 150 mm×6.0 mm,5μm） packed with stationary phase,as the mobile phase with a flow rate of 1 mL per minute,a mixture of 65 volume of phosphoric acid （0.1%）（containing po- tassium dihydrogen orthophosphate 0.34%）and 35 volume of methanol,and detection wavelength was at 205 nm.Re- sult:The linear ranges of dextromethorphan,guaiphenesin hydrobromide,chlorphenamine maleate and methylephedrine hydrochloride were 6-0,20-100,0.6-3,4-20 μg·mL^-1;and their average recoveries were 103.3%,98.6%, 95.8% and 98.5%,respectively.In three batches of samples,the total content of impurities was less than 0.6%.A- mong them,the material of higher content was not more than 0.2%.Conclusion:This method is fast.The informations provided have great capacity.Furthermore,acid,alkali and oxidize breakage verification is adopted in order to get an assurance of the result.This method is satisfied with a excellent resolution in all new produced impurity.更多还原