HPLC同时测定复方倍他米松注射液中倍他米松磷酸钠和二丙酸倍他米松的含量  

Simultaneous HPLC determination of betamethasone sodium phosphate and betamethasone dipropionate in compound betamethasone injection

作　　者：金薇[1] 汪洁[1] 

机构地区：[1]上海市药品检验所,上海200233

出　　处：《中国药学杂志》2002年第1期48-50,共3页Chinese Pharmaceutical Journal

摘　　要：目的　测定复方倍他米松注射液中倍他米松磷酸钠和二丙酸倍他米松的含量。方法　采用高效液相色谱法 ,以甲醇 0 .0 5mol·L-1磷酸二氢钾溶液为流动相进行梯度洗脱 ,以氟米松为内标 ,检测波长为 2 5 4nm。结果　倍他米松磷酸钠和二丙酸倍他米松分别在浓度为 0 .0 37～ 0 .36 6mg·mL-1(r =1.0 0 0 0 ,n =6 )和 0 .0 87～ 0 .86 8mg·mL-1(r=0 .9996 ,n =6 )范围内呈良好线性关系。倍他米松磷酸钠和二丙酸倍他米松的平均加样回收率分别为 10 1.3%(RSD =1.3%,n =9)和 99.0 %(RSD =1.3%,n =9)。结论　方法简便、快速、准确 ,能同时测定复方倍他米松注射液中倍他米松磷酸钠和二丙酸倍他米松。OBJECTIVE A reversed phase HPLC method was developed to determine the contents of betamethasone sodium phosphate and betamethasone dipopinate simultaneously in compound betamethasone injection.METHODS The analysis was carried on a column of Shim-Pack CLC-ODS (4.6 mm×150 mm) with a mobile phase of methanol-0.05 mol·L -1 potassium dihydrogen phosphate solution (gradient elution from 58∶42 to 75∶25 in 18 minutes),using fluoromethasone as the internal substance.The detection wavelength was at 254 nm.RESULTS The linear range was 0.03 664～0.3 664 mg·mL -1(r=1.000 0,n=6) for betamethasone sodium phosphate and 0.087～0.868 mg·mL -1 for betamethasone dipropionate (r=0.999 6,n=6).The average recoveries of betamethasone sodium phosphate and betamethasone dipropionate were 101.3% (RSD=1.3%,n=9) and 99.0% (RSD=1.3%,n=9),respectively.The reproducibilities of the method (RSD) were 0.31% and 0.14% (n=7),respectively.CONCLUSION This method is rapid,simple and accurate.

关 键 词：高效液相色谱法 复方倍他米松注射液 倍他米松磷酸钠 二丙酸倍他米松 氟米松 HHPLC 含量 

分 类 号：R927.2[医药卫生—药学]