The design and use of a simple System Suitability Test Mix for generic reverse phase high performance liquid chromatography–mass spectrometry systems and the implications for automated system monitoring using global software tracking

Generic reversed‐phase ultra‐high‐pressure liquid chromatography methodology developed by using computer‐assisted modeling for streamlined performance evaluation of a wide range of stationary phase columns

“…To achieve this, a multi‐component test mixture based on the one previously developed by Mutton et al. for system suitability testing was selected [35]. The seven components (3‐bromo guanosine 3′‐5′‐cyclic monophosphate, amytryptine, 4‐chloro cinnamic acid, diethyl phthalate, diamyl phthalate, dihexyl phthalate, dioctyl phthalate) possess different chemical moieties and functionalities, thus covering a wide range of polarity.…”

“…Once the selection of the columns to be used in the screening process has been made, the focus shifted towards the development of a generic probe methodology capable of monitoring different chromatographic parameters, as well as stability across all stationary phases and, finally, selectivity at different pH values. To achieve this, a multicomponent test mixture based on the one previously developed by Mutton et al for system suitability testing was selected [35]. The seven components (3-bromo guanosine 3′-5′-cyclic monophosphate, amytryptine, 4-chloro cinnamic acid, diethyl phthalate, diamyl phthalate, dihexyl phthalate, dioctyl phthalate) possess different chemical moieties and functionalities, thus covering a wide range of polarity.…”

Maintaining a High-Quality Screening Collection: The GSK Experience

“…Full-scan mode was used for detecting ions between 100 and 1000 Da at a scan rate of 0.5 s. The system was controlled using MassLynx software (Waters). The LC-MS instrument was validated prior to each experiment using repeat injections of a system suitability test mix 12,14 to check the reproducibility. During the experiments, system suitability samples were analyzed at the beginning and at the end of a batch of samples to ensure correct functioning of the instrument.…”

Method Development and Application of an Accelerated Solution Stability Screen for Drug Discovery

“…The seven-component test mix was a DMSO solution of 8-bromoguanosine, amitriptyline-HCl, 4-chlorocinnamic acid, diethyl phthalate, di-amyl phthalate, di-n-hexyl phthalate, and dioctyl phthalate. 9,10 The concentration of each component was chosen taking care not to saturate any of the detectors. A control with known stability in the assay buffers was also used to confirm the reproducibility of results.…”