反相高效液相色谱法同时测定扑麻滴鼻剂中3组分的含量

Simultaneous Determination of Three Components of Puma Nose Drops by RP-HPLC

.目的 :建立以反相高效液相色谱法同时测定扑麻滴鼻剂中马来酸氯苯那敏、呋喃西林和盐酸麻黄碱含量的方法。方法 :色谱柱为XDBC8;流动相由甲醇 (A)、乙腈 (B)和0. 02mol/L磷酸二氢钾溶液 (含0. 2 %乙三胺 ,磷酸调pH至3. 0 ,C)组成 ,进行线性梯度洗脱 (0min～3. 5min ,A∶B∶C=6∶13∶81 ;8. 5min以后 ,A∶B∶C=6∶30∶64) ;流速为1. 0ml/min ;柱温为30℃ ;检测波长为254nm ;内标为氯霉素。结果 :马来酸氯苯那敏、呋喃西林、盐酸麻黄碱检测浓度分别在0 .04～0. 20、0. 02～0. 10、0 .50～2. 50mg/ml范围内线性关系良好 ;平均回收率分别为99. 44 % (RSD=0 .48 % ,n=3)、101 .36 % (RSD=0. 41 % ,n=3)、99. 43 %(RSD=0 .59 % ,n=3)。结论 :本方法可靠、简便、准确 ,可用于扑麻滴鼻剂的质量控制。

OBJECTIVE:To establish a RP-HPLC method for simultaneous determination of chlorapheniramine maleate,furacilin and ephedrine hydrochloride in Puma nose drops.METHODS:The analysis was carried on a XDB C 8 column;the moˉbile phase was composed of methanol(A),acetonitrile(B)and0.02mol/L potassium dihydrogen phosphate solutions(containing0.2%triethylamine and adjusted to pH3.0with phosphoric acid,C)with linear gradient elution(0min～3.5min,A∶B∶C=6∶13∶18,8.5min,A∶B∶C=6∶30∶64)and the flow rate was1.0ml/min;the detection wavelength was254nm and the column temperature was30℃.Chloramphenicol was used as the internal standard.RESULTS:The linear ranges were0.04～0.20mg/ml for chlorapheniramine maleate,0.02～0.10mg/ml for furacilin,0.50～2.50mg/ml for ephedrine hydrochloˉride.The average recoveries were99.44%(RSD=0.48%,n=3)for chlorapheniramine maleate,101.36%(RSD=0.41%,n=3)for furacilin and99.43%(RSD=0.59%,n=3)for ephedrine hydrochloride.CONCLUSION:The method is reliable,accurate and suitable for quality control of Puma nose drops.