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目的探讨他克莫司胶囊溶出度的测定方法。方法溶出度测定采用浆法,转速为100r/min,水为溶出介质。同时比较了水、0.1mol/LHCL以及pH6.8的磷酸盐缓冲液三种溶出介质。测定采用高效液相色谱法,确定色谱条件为乙腈-水(75∶25),流速为1.0ml/min,检测波长为210nm。结果确立了以水为溶出介质、浆法转速为100r/min的溶出方法。以水为溶出介质时,需静置6~10h达到异构平衡,峰面积重复性较好。结论该法测定他克莫司胶囊的溶出度,检测条件无缓冲盐系统,简便易行,重现性好,结果准确,可用于他克莫司胶囊溶出度检测。
Objective To investigate the dissolution of tacrolimus capsules. Method Dissolution was determined by the method of slurry, speed 100r / min, water as dissolution medium. At the same time, three dissolution media of water, 0.1mol / LHCL and pH6.8 phosphate buffer were compared. Determination of high performance liquid chromatography to determine the chromatographic conditions of acetonitrile - water (75:25), the flow rate of 1.0ml / min, the detection wavelength was 210nm. The results established with water as the dissolution medium, pulp speed of 100r / min dissolution method. Water as the dissolution medium, to be placed 6 ~ 10h to achieve isomeric equilibrium peak area reproducibility is better. Conclusion The method for the determination of tacrolimus capsules dissolution, detection conditions without buffer system, simple, reproducible, accurate and can be used for tacrolimus capsule dissolution testing.