The goal of this study is to demonstrate method equivalency between the ACQUITY™ UPLC™ H-Class PLUS Binary System and ACQUITY UPLC System for the analysis of the USP method for budesonide.
The isocratic UPLC method based on the original USP method for budenoside analysis was successfully transferred from the ACQUITY UPLC System to the ACQUITY UPLC H-Class PLUS Binary System. All criteria assessments showed excellent agreement, easily satisfying any criteria laid down in a method transfer protocol, which is essential in a quality-controlled environment.
The ACQUITY UPLC H-Class PLUS Binary System has shown to be a demonstrably robust platform for transferring the described method, exhibiting consistent retention times, RRT’s, and resolution. All system suitability results were satisfied according to the criteria laid down in the original USP method.