AQbD For The Analysis Of Dexamethasone Phosphate And Related Compounds Using Arc Premier MaxPeak High Performance Surfaces (HPS) Technology

By Fadi L. Alkhateeb and Paul D. Rainville, Waters Corporation

Stainless-steel has been the most commonly used material to construct liquid chromatography instruments and columns due to its corrosion resistance, manufacturability, and its inertness to a wide variety of chemical compounds. However, certain classes of analytes, such as metal chelating compounds/Lewis bases can interact with metal oxide films because of the electron deficient nature of these metal ions.

One approach that has previously been used to address this issue was adding metal chelators such as EDTA, citric acid, and acetone to the mobile phase. Despite the potential advantages of these additives, the use of these chelators can have undesired impacts on chromatographic selectivity and MS detection sensitivity.

To combat these issues, Waters has recently developed a family of technologies named MaxPeak High Performance Surfaces (HPS). The MaxPeak HPS LC surfaces are composed of a highly cross-linked layer related to that of ethylene bridged hybrid (BEH) chromatographic particles. These surfaces are designed to increase analyte recovery, sensitivity, and reproducibility by mitigating undesired interactions with metal surfaces.

In this application note, a UHPLC method for the analysis of metal-sensitive pharmaceuticals/related compounds using MaxPeak HPS systems and columns was developed. The experiments were performed using an Arc Premier System that is equipped with a column manager and solvent select valve to allow for automated exploration of a wide range of conditions. DryLab4 method development software was used in this study to automate the method development process according to AQbD principles.

Read how the analysis of phosphorylated compounds using an Arc Premier System in combination with MaxPeak Premier Columns provided superior chromatographic performance when compared to stainless-steel hardware. Employing the AQbD principles in analytical method development helped in obtaining robust and reproducible method.