Supercritical fluid chromatography versus liquid chromatography for the enantiomeric separation of itraconazole.

• SFC and NP-LC technique is used to separate itraconazole stereoisomers. • We developed a rapid and green method for the separation of itraconazole stereoisomers. • This platform will aid in the Quality control Laboratories to adapt Eco-friendly method. Separation of the stereoisomers of the antifungal drug itraconazole using supercritical fluid chromatography and normal-phase liquid chromatography is presented. The performances of the two methods are evaluated based on their speed, resolution, and the analytical method greenness score. Both methods achieve baseline separation and meet the United States Pharmacopeia-recommended resolution of ≥1.5 between the four stereoisomers. The methods are validated following the International Conference on Harmonization guidelines and evaluated in terms of specificity, precision, linearity, accuracy, and range; they are thus appropriate for purposes of quantification. Supercritical fluid chromatography achieves separation more rapidly and is found to be more eco-friendly than normal-phase liquid chromatography. To emphasize the use of ecofriendly alternatives, the assessment is performed using a metric termed as the analytical method greenness score. The method can thus be implemented for determination of chiral purity in various Quality control laboratories. [ABSTRACT FROM AUTHOR]