RP-HPLC法测定复方甲硝唑涂剂中甲硝唑和醋酸泼尼松的含量

Content Determination of Metronidazole and Prednisone Acetate in Compound Metronidazole Pigmentum by RP-HPLC

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.