HPLC法同时测定复方雌二醇控释贴片中雌/孕激素的含量

Determination of Compound Estradiol ControlledDelivery Patches by HPLC

目的：建立同时测定复方雌二醇透皮控释贴片中雌二醇（Ｅ２）和炔诺酮醋酸酯（ＮＥＴＡ）含量的反相ＨＰＬＣ法。方法：色谱柱为岛津ＯＤＳ柱（５μｍ，６０ｍｍ×１５０ｍｍ）；检测波长为２８０ｎｍ（０→８５ｍｉｎ），２４０ｎｍ（８５１→１５ｍｉｎ）；流动相为甲醇－水（７５∶２５）。结果：Ｅ２、ＮＥＴＡ线性范围分别为２０～２０、６０～６０ｍｇ·Ｌ－１。平均回收率分别为１０１０％（ＲＳＤ＝１６％）、９９７％（ＲＳＤ＝１４％）。结论：本法操作简单、精确、快速。

Objective: To develop a HPLC method for assaying estradiol(E2)and norethindrone acetate(NETA)in compound estradiol controlled delivery patches simultaneously Method: With Shim-pack CLC C18(5m)column(60 mm150 mm),methanol and water(7525)as mobile phase,detector set at 280nm(0850 min),240 nm(85115 min). Results: Linear ranges of E2 and NETA were 2020 mgL-1 and 6060 mgL-1,respectivelyThe average recovery rates(n=5)of E2 and NETA were 1010%(RSD=16%)and 997%(RSD=14%),respectively. Conclusion:This method provides a simple,rapid and accurate way to control the quality of compound estradiol controlled delivery patches