SUPERCRITICAL FLUID CHROMATOGRAPHY IN THE ROUTINE STABILITY CONTROL OF ANTIPRURITIC PREPARATIONS

A recently developed system for supercritical fluid chromatography (SFC), based on independent flow and pressure control and suitable for packed and capillary columns, was tested on a routine level for the reliable, accurate and precise determination of active pharmaceutical substances in stability control. Only packed columns were used for this analysis. The chromatographic figures of merit and the validation data of the active substance alone and in two different dosage forms (accuracy, 98.8-99.2%; precision, 0.6%; linearity of response, 0.998-0.999) are comparable with the former liquid chromatographic methods. Economical (reduction of analysis time, fewer experimental steps and less sample pre-separation) and ecological (carbon dioxide instead of organic solvents) advantages make SFC an attractive alternative to liquid chromatography in the determination of crotamiton.