高效液相色谱法测定鼻炎灵喷雾剂中马来酸氯苯那敏、盐酸麻黄碱、乳酸环丙沙星的含量  

Detemination of chlorpheniramine,ephedrine hydrochloride,ciprofloxacin lactate in Biyanling nasal spray by HPLC

作　　者：赵玉兰[1] 廖杰[1] 孙荣新[1] 

机构地区：[1]解放军总医院医学实验测试中心,北京100853

出　　处：《中国药学杂志》2001年第7期472-474,共3页Chinese Pharmaceutical Journal

摘　　要：目的　采用反相高效液相色谱法 ,对鼻炎灵喷雾剂中马来酸氯苯那敏、盐酸麻黄碱、乳酸环丙沙星等组分进行了分离 ,建立含量测定方法。方法　用呋喃西林为内标 ,采用ZorbaxSB C18柱分离 ,0 .0 2 5mol·L-1磷酸盐缓冲液 甲醇 (6 5∶35 )为流动相 ,检测波长 2 5 8nm。结果　标准曲线范围分别为马来酸氯苯那敏 0 .15～ 1.5 3mg·mL-1,r =0 .9998。盐酸麻黄素为 0 .71～ 7.15mg·mL-1,r=0 .9999;乳酸环丙沙星为 0 .0 3～ 0 .2 9mg·mL-1,r=0 .9999。最低检测浓度分别为 1.0 4,4.89,0 .39μg·mL-1。方法的回收率分别为 99.6 8% (n =5 ) ,99.88% (n =10 ) ,98.72 (n =8)。日内RSD分别为 0 .2 5 %～ 0 .6 8% ,0 .79%～ 1.81% ,0 .95 %～ 1.84%。日间RSD分别为 0 .87%～ 3.81% ,1.49%～ 3.78% ,2 .2 8%～ 3.0 2 %。结论　此方法快速、准确。OBJECTIVE A HPLC method was established for the determination of chlorpheniramine,ephedrine hydrochloride and ciprofloxacin lactate in Biyanling nasal spray simutaneously.METHODS Furacilin was used as the internal standard.The separation was carried out on a ZorbaxSB C 18 column 0.025 mol·L -1 phosphate buffer:methanol (65∶35) was used as a mobile phase.The detection wavelength was at 258 nm.RESULTS The standard curves were linear over the range of 0.15～1.53 mg·mL -1 for chlorpheniramine ( r = 0.999 8 );0.71～7.15 mg·mL -1 for ephedrine hydrochloride ( r = 0.999 9 ) and 0.03～0.29 mg·mL -1 for ciprofloxacin lactate ( r = 0.999 9 ),respectively with the limits of detection 1.04,4.89 and 0.39 μg·mL -1 ,respectively.The average recoveries of chlorpheniramine,ephedrine hydrochloride and ciprofloxacin lactate were 99.68%( n =5),99.88( n =10) and 98.72( n =8) respectively.The within day RSD were 0.25% ～0.68%;0.79%～1.81% and 0.95%～1.84%,The between day RSD of them were 0.87%～3.81%,1.49%～3.78% and 2.28% ～ 3.02% respectively.CONCLUSION The method was simple,rapid,sensitive and reproducible.

关 键 词：马来酸氯苯那敏 盐酸麻黄碱 乳酸环丙沙星 高效液相色谱法 鼻炎灵喷雾剂 

分 类 号：R987[医药卫生—药品] R927.2[医药卫生—药学]