醇清软膏质量标准的研究  

RP-HPLC Determination of Estradiol in Chunqing Ointment

作　　者：胡斌[1] 林彩[1] 邓莉[1] 贺红军[1] 

机构地区：[1]第三军医大学西南医院药学部,重庆400038

出　　处：《中国药业》2007年第23期13-14,共2页China Pharmaceuticals

摘　　要：目的测定醇清软膏中雌二醇的含量。方法采用反相高效液相色谱法,色谱柱为C18柱,流动相为甲醇-水(75∶25),检测波长280nm,流速1.0mL/min,柱温30℃,进样量10μL。结果雌二醇质量浓度在1.96～5.88μg/mL范围内与峰面积线性关系良好(r=0.9998),日内和日间精密度的RSD均小于2%,平均加样回收率为100.6%,5批供试品的平均含量为标示量的96.34%。结论反相高效液相色谱法操作简单,检测结果准确可靠,可用于醇清软膏的质量控制。Objective To develop a method for determining the content of estradiol in Chunqing Ointment. Methods The chromatographic system consisted of C18 column and the mobile phase of MeOH-H20 （75：25）,with the detection wavelength at 280 nm, The flow rate was 1.0 mL/min. The column temperature was 30℃, the sample size was 10 μL Results The linear range was 1.96 - 5.88 μg/mL （ r = 0. 999 8）, the RSD of intra- and inter-day was less than 2%, and the average recovery rate was 100. 6% （n =3）. The average content of the 5 batches sample was 96.34%, Conclusion Without complicated sampling procedure, the method is simple, rapid and accurate for the assay of the components in this pharmaceutical formulation,

关 键 词：雌二醇 反相高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学] R984