高效液相色谱法测定复方达克罗宁乳膏中盐酸达克罗宁、马来酸氯苯那敏、地塞米松磷酸钠的含量

目的建立高效液相色谱法测定复方达克罗宁乳膏中盐酸达克罗宁、马来酸氯苯那敏、地塞米松磷酸钠含量的方法。方法采用高效液相色谱法。色谱柱为VP-ODS C18柱(250 mm×4.6 mm,5μm);流动相为磷酸缓冲液-乙腈(80∶20);流速:1.0 mL.min-1;测定波长:240 nm;柱温:30℃:进样:10μL。结果该方法不受处方中基质干扰。盐酸达克罗宁、马来酸氯苯那敏、地塞米松磷酸钠的线性范围分别为0.100 3~0.702 1μg(r=0.999 8,n=6),0.028 56~0.199 9μg(r=0.999 9,n=6),0.006 694~0.046 85μg(r=0.999 7,n=6),平均回收率分别为98.8%、99.0%、99.0%,RSD分别为0.97%、1.3%、0.98%(n=9)。结论该方法操作简便,灵敏度高,重现性好,可用于复方达克罗宁乳膏中盐酸达克罗宁、马来酸氯苯那敏、地塞米松磷酸钠的含量测定。

Simultaneous determination of dyclonine,chlorphenamine maleate,and dexamethasone sodium phosphate in compound dyclonine ointment by HPLC

Objective To establish an HPLC method for simultaneous determination of dyclonine chlorphenamine maleate,and dexamethasone sodium phosphate in compound dyclonine ointment.Methods The column was VP-ODS C18（250 mm ×4.6 mm,5 μm）,the mobile phase was composed of phosphate buffer-acetonitrile（80∶20） at 1.0 mL·min-1,the detection wavelength was 240 nm,the column temperature was 30 ℃,and the injection volume was 10 μL.Results The linear ranges of dyclonine,chlorphenamine maleate and dexamethasone sodium phosphate were 0.100 3-0.702 1 μg（r=0.999 8,n=6）,0.028 56-0.199 9 μg（r=0.999 9,n=6）,and 0.006 694-0.046 85 μg（r=0.999 7,n=6）respectively.The average recoveries of dyclonine,chlorphenamine maleate dexamethasone sodium phosphate were 98.8%,99.0%,and 99.0%,and RSD were 0.97%,1.3%,and 0.98 %（n=9）.Conclusion The method is simple and accurate with high sensitivity and good repeatability,which can be used to control the quality of compound dyclonine ointment.