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目的：建立反相高效液相色谱法分别测定体外释药试验接收液中吲哚美辛浓度和贴剂含药量，寻找月桂氮酮在透皮吸收制剂中的最佳浓度。方法：接收液中加入炔诺酮作为内标，经乙醚萃取后，选用ＬｉｃｈｒｏｓｏｒｂＲＰ１８（４．６ｍｍ×２５０ｍｍ，５μｍ）柱，流动相为甲醇水乙腈冰醋酸（６３∶２２∶１５∶０．１５），流速０．８ｍｌ·ｍｉｎ－１，检测波长２５４ｎｍ；贴剂先用医用汽油溶出，ｐＨ７．２磷酸缓冲液提取，再如上测定。结果：两峰分离完全，吲哚美辛线性范围０．８μｇ·ｍｌ－１～２０μｇ·ｍｌ－１，ｒ＝０．９９９８，检测限为２ｎｇ，日内偏差和日间偏差分别为０．９２％（ｎ＝５）和０．３７％（ｎ＝５），接收液和贴剂中吲哚美辛测定方法的平均回收率分别为９９．９８％（ＲＳＤ＝０．２０％）和９２．２６％（ＲＳＤ＝０．８１％）；贴剂中吲哚美辛平均含量为标示量的９２．７４％（ＲＳＤ＝１．８０％）；得月桂氮酮的最佳处方浓度为６．４６％。结论：方法灵敏，满足了吲哚美辛透皮制剂研究的需要
OBJECTIVE: To establish an RP-HPLC method for the determination of indomethacin concentration and patch dosage in the drug-receiving test solution of in vitro release test, in order to find out the best concentration of azinon ketone in transdermal absorption preparation. Methods: Norethindrone was added as the internal standard in the receiving solution. After extraction with diethyl ether, Lichrosorb RP18 (4.6 mm × 250 mm, 5 μm) column was used. The mobile phase was methanol water acetonitrile glacial acetic acid (63:22:15 : 0.15), the flow rate of 0.8ml · min-1, detection wavelength of 254nm; patch first with medical gasoline dissolution, pH7.2 phosphate buffer extraction, and then measured. Results: The two peaks were completely separated. The linear range of indometacin was 0.8μg · ml-1 ~ 20μg · ml-1, r = 0.9998 with the detection limit of 2ng. The intra-day and intra-day deviations were 0.92% (N = 5) and 0.37% (n = 5) respectively. The average recoveries of the indometacin determination methods in the receiving solution and patch were 99.98% (RSD = 0.20%) and 92.26 % (RSD = 0.81%). The average content of indomethacin in the patch was 92.74% of the labeled amount (RSD = 1.80%). The best prescription concentration of azinon was 6.46 %. Conclusion: The method is sensitive and meets the need of indomethacin transdermal preparation research