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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 transdermal controlled release formulation and dissolution by reversed-phase high performance liquid chromatography. Column SperisorbC18 (4.6 × 250mm); mobile phase: methanol-water (75:25); detection wavelength: 280nm. Dissolution rate measured by the pulp method, speed 30rpm / min; dissolution medium: 1% polyethylene glycol -400. The linear range was 5.0 ~ 80.0μg / ml (n = 5, r = 0.996). The lowest detectable level of estradiol was 5ng and the average recovery was 99.27% (RSD = 0.3%). The intra- and interday RSD were 1.93% (n = 5) and 2.45% (n = 5). The cumulative dissolution rate of 168 h was more than 80%. The dissolution of different batches of E2-TDS was reproducible. The method is simple, rapid and accurate and provides a new analytical method for the quality control of transdermal agents.