中国临床药学杂志

目的采用HPLC法测定复方泼尼松龙滴鼻液中醋酸泼尼松龙和马来酸氯苯那敏的含量。方法色谱柱为C18,流动相为甲醇-0.02 mol.L-1磷酸二氢钾溶液(含0.2%三乙胺,用H3PO4调pH至3.0)(55∶45,V/V),检测波长262 nm,流速1 mL.min-1,柱温为室温。结果醋酸泼尼松龙和马来酸氯苯那敏分别在25.2~604.8 mg.L-1(r=0.999 9)、25.5~612.0 mg.L-1(r=0.999 9)内线性关系良好,平均回收率分别为99.2%(RSD=0.99%)、99.1%(RSD=1.00%)。结论本方法操作方便,准确性、重现性好,可测定醋酸泼尼松龙和马来酸氯苯那敏的含量。

AIM To establish a method for determination of prednisolone acetate and chlorpheniramine maleate in compound prednisolone nasal drops by HPLC.METHODS The content determination was performed on column C18;the mobile phase consisted of methanol 0.02 mol·L-1 potassium dihydrogen phosphate solution(containing 0.2% triethylamine and adjusted to pH 3.0 with phosphoric acid)(55∶45,V/V);the detection wavelength was 262 nm;the flow rate was 1 mL·min-1 and the column temperature was room temperature.RESULTS The linear ranges of prednisolone acetate and chlorpheniramine maleate were 25.2-604.8 mg·L-1(r=0.999 9) and 25.5-612.0 mg·L-1(r=0.999 9),respectively.The average recoveries were 99.2%(RSD=0.99%) and 99.1%(RSD=1.00%),respectively.CONCLUSION The method is simple,accurate,reproducible,and suitable for the determination of prednisolone acetate and chlorpheniramine maleate.