BP薄层附录.docx

Appendix III A(Ph. Eur. method 2.2.27)Thin-layer chromatography is a separation technique in which a stationary phase consisting of an appropriate material is spread in a uniform thin layer on a support (plate) of glass, metal or plastic. Solutions of analytes are deposited on the plate prior to development. The separation is based on adsorption, partition, ion-exchange or on combinations of these mechanisms and is carried out by migration (development) of solutes (solutions of analytes) in a solvent or a suitable mixture of solvents (mobile phase) through the thin-layer (stationary phase).ApparatusPlates? The chromatography is carried out using pre-coated plates as described underReagents (4.1.1). Preconditioning of the plates? It may be necessary to wash the plates prior to separation. This can be done by migration of an appropriate solvent. The plates may also be impregnated by procedures such as development, immersion or spraying. At the time of use, the plates may be activated, if necessary, by heating in an oven at 120 °C for 20 min.Chromatographic tank? A chromatographic tank with a flat bottom or twin trough, of inert, transparent material, of a size suitable for the plates used and provided with a tightly fitting lid is required. For horizontal development the tank is provided with a trough for the mobile phase and it additionally contains a device for directing the mobile phase to the stationary phase.Micropipettes, microsyringes, calibrated disposable capillaries? or other application devices suitable for the proper application of the solutions.Fluorescence detection device? to measure direct fluorescence or the inhibition of fluorescence.Visualisation reagents? Suitable devices are used for derivatisation to transfer to the plate reagents by spraying, immersion or exposure to vapour and, where applicable, to facilitate heating for visualisation of separated components.Documentation? A device may be used to provide documentation of the