RP-HPLC法测定雌二醇透皮控释制剂的含量和溶出度

RP-HPLC DETERMINATION OF ESTRADIOL IN E_2-TDS AND ITS DISSOLUTION

采用反相高效液相色谱法测定雌二醇透皮控释制剂的含量和溶出度。色谱柱SperisorbC18（4.6×250mm）;流动相：甲醇-水（75：25）;检测波长：280nm。溶出度用浆法测定，转速30rpm／min;溶出介质：1％聚乙二醇-400。线性范围：5.0～80.0μg／ml（n=5，r=0.996），雌二醇最低检出量为5ng，平均回收率：99.27％，（RSD=0.3％），日内和日间RSD分别为1.93％（n=5）和2.45％（n=5），168h的累积溶出度大于80％，不同批号E2-TDS溶出度测定重现性良好。方法操作简便，快速，准确，为透皮制剂的质量控制提供了新的分析方法。

Determination of estradiol in estradiol transdermal delivery system E2-TDS and its dissolution by RP-HPLC. Sperisorb C18 column (4. 6×250mm, 5μm), mobile phase: CH3OH-H2O (75: 25 ),UV detection at 280nm,a paddle method was used to study the dissolution, the rotative relocity was 30rpm/min and the solvent was 100ml of 1% PEG400. The linear range of standard curve was 5.0-80.0 μg/ml, r=0.996 (n=5). The average recovery of assay was 99.27% with a relative standard deviation of 0. 43% (n=3), the preciscin within-day RSD was 1. 93% (n=5 ), the dissolution profiles were found to be virtully superimposible for different batches of E2TDS. The accumlative release rate over 80% in 168h,the dissolution protiles were found to be virtually superimposalle for different fatch of E2-TDS.