Validation of supercritical fluid chromatographic methods

Method validation is the process of proving that an analytical method is acceptable for its intended purpose. The present chapter defines the validation criteria described in regulatory documents, especially focused on the ICH Q2(R2) and Q14 effective in 2024. Despite the abundance of guidelines, the conclusion about method validity remains confused. In this context, the state-of-the-art validation methodology named total error, or combined approach, is briefly explained as the methodology that should be followed for all method validations. Finally, a review of literature presents quantitative development and validation of supercritical fluid chromatography methods considering a wide range of applications and analytical fields.