title: Expediting the method development and quality control of reversed-phase liquid chromatography electrospray ionization mass spectrometry for pharmaceutical analysis by using an LC/MS performance test mix.
abstract: Mass spectrometry combined with liquid chromatography (LC/MS) has become an important analytical methodology in both pharmaceutical and biomolecule analyses. LC/MS, especially with reversed-phase HPLC (RP-LC), is extensively used in the separation and structural identification of pharmaceutical samples. However, many parameters have to be considered when a new LC/MS method is developed for either separation and structural analysis of unknown mixtures or quantitative analysis of a set of known compounds in an assay. The optimization of a new LC/MS method can be a time-consuming process. A novel kit-LC/MS performance test mix-composed of aspartame, cortisone, reserpine, and dioctyl phthalate has been developed to accelerate the process of establishing a new RP-LC/MS method. The LC/MS mix makes the evaluation and validation of an LC/MS method more efficient and easier. It also simplifies the quality control procedure for an LC/MS method in use.
authors.affiliation: Affymax Research Institute, Palo Alto, California 94304, USA.
authors.forename: L
authors.initials: L
authors.lastname: Tang
authors.forename: W L
authors.initials: WL
authors.lastname: Fitch
authors.forename: M S
authors.initials: MS
authors.lastname: Alexander
authors.forename: J W
authors.initials: JW
authors.lastname: Dolan
mesh_terms: D002851:Chromatography, High Pressure Liquid; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011786:Quality Control; D021241:Spectrometry, Mass, Electrospray Ionization
chemical_list: D004364:Pharmaceutical Preparations