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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 To determine the contents of betamethasone dipropionate and betamethasone dipropionate in compound betamethasone injection. Methods High performance liquid chromatography (HPLC) was used with gradient elution of methanol 0. 05mol·L-1 potassium dihydrogen phosphate solution as mobile phase and flumethasone as internal standard. The detection wavelength was 254nm. Results betamethasone sodium phosphate and betamethasone dipropionate at the concentrations of 0. 037 ~ 0. 36 6mg · mL-1 (r = 1.0 0 0 0, n = 6) and 0.87 ~ 0. 86 8mg · mL-1 (r = 0.9996, n = 6) showed a good linear relationship. The average recoveries of betamethasone sodium and betamethasone dipropionate were 10 1.3% (RSD = 1.3%, n = 9) and 99.0% (RSD = 1.3%, n = 9), respectively. Conclusions The method is simple, rapid and accurate and can be used for the simultaneous determination of betamethasone sodium and betamethasone dipropionate in compound betamethasone injection.