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他克莫司胶囊含量与溶出方法学研究 被引量:3

Determination of The Content and Dissolution of Tacrolimus Capsules
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摘要 目的:建立他克莫司胶囊溶出度及含量的测定方法。方法:采用高效液相色谱法(HPLC)测定他克莫司胶囊含量与溶出度,流动相为乙腈-水(75∶25),流速为1.0 mL.min-1,检测波长为210 nm,柱温50℃,进样量20μL。结果:他克莫司在浓度0.007~0.124 mg.mL-1范围内,峰面积和浓度线性关系良好,Y=12 254 969.460 5X-11 833.369 0,r=0.999 5;溶出度、含量重现性良好,RSD分别为1.08%、0.86%;平均回收率为99.71%(n=9),RSD为0.63%。以水为溶出介质时,需静置6~10 h达到异构平衡,峰面积重复性较好。结论:HPLC测定他克莫司胶囊的含量与溶出度,重现性好、结果准确、易于操作,可用于他克莫司胶囊溶出度及含量检测。 OBJECTIVE : To establish a method for determining the dissolution METHODS: HPLC was adopted for determination of the dissolution and content and content of tacrolimus capsules. of tacrolimus capsules. The mobile phase consisted of acetonitrile-water (75: 25) with detection wavelength of 210 nm, flow rate of 1.0 mL-min^-1, column temperate of 50 ℃and sample size of 20 μL. RESULTS: The peak area and concentration showed good linearity when the concentration of tacrolimus was at a range of O. 007-0. 124 mg. mL^-1 ( Y = 12 254 969. 460 5X - 11 833.369 0,r = 0. 999 5). The dissolution and content of tacrolimus showed good reproducibility, with RSD of 1.08% and 0. 86% , respectively. The average recovery rate of tacrolimus was 99. 71% (n = 9,RSD = 0. 63% ). When water was selected as dissolution media, 6-10 hours' standing time was needed for the solution to achieve tautomeric equilibrium and the peak area showed good reproducibility. CONCLUSION: The established HPLC method for determination of the dissolution and content of tacrolimus capsules was proved to be reproducible, accurate in results and easy to operate and thus it can be used for determining the dissolution and content of tacrolimus capsules.
作者 刘桦 孙为玉
出处 《中国医院用药评价与分析》 2012年第8期716-719,共4页 Evaluation and Analysis of Drug-use in Hospitals of China
关键词 他克莫司 溶出度 含量 异构平衡 Tacrolimus Dissolution Content Tautomeric equilibrium
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