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

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

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。

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.