摘要
目的:建立同时测定复方甲硝唑涂剂中甲硝唑和醋酸泼尼松含量的方法。方法:采用反相高效液相色谱法。色谱柱为DiamonsilC18,流动相为甲醇-水,梯度洗脱,流速为1.0ml/min,检测波长为238nm,柱温为20℃。结果:甲硝唑和醋酸泼尼松检测质量浓度线性范围分别为100.0~800.0(r=0.9997)、20.0~200.0(r=0.9998)μg/ml,平均回收率分别为101.3%(RSD=1.6%,n=6)、100.3%(RSD=1.8%,n=6)。结论:本方法准确度、精密度好,可用于含甲硝唑、醋酸泼尼松的复方制剂的质量控制。
OBJECTIVE:To develop the method for simultaneous determination of metronidazole and prednisone acetate in Compound metronidazole pigmentum.METHODS:RP-HPLC method was adopted.The determination was performed on Diamonsil C 18 column with mobile phase consisted of methanol-water(gradient elution)at the flow rate of 1.0 ml/min.The detection wavelength was set at 238 nm and column temperature was 20 ℃.RESULTS:The linear ranges of metronidazole and prednisone acetate were 100.0-800.0 μg/ml (r=0.999 7) and 20.0-200.0 μg/ml (r=0.999 8),respectively;the average recoveries were 101.3% (RSD=1.6%,n=6)and 100.3%(RSD=1.8%,n=6),respectively.CONCLUSIONS:The method is good in accuracy and precision,and it is suitable for quality control of compound preparation containing metronidazole and prednisone acetate.
出处
《中国药房》
CAS
CSCD
2013年第13期1218-1219,共2页
China Pharmacy