title: Systematic development and validation of stability indicating micellar electrokinetic chromatography methods for early stage drug candidates.
abstract: Suitable methods for assessment of purity, potency and stability of new drug substances and drug products are required to be rapidly developed and validated to provide appropriate data for early project development decisions. In order to routinely provide methods of consistent and suitable quality to meet increasingly aggressive timelines, systematic approaches to both develop and validate analytical technologies have been developed. Systematic approaches to evaluate separation parameters such as buffer pH, buffer ionic strength, surfactant concentration, organic modifiers, organic modifier concentration, applied voltage and temperature were evaluated for an early stage drug candidate. Techniques to improve method precision and ruggedness were also examined. Finally, the validation results from the micellar electrokinetic chromatography method utilizing an internal standard were compared against the simultaneously developed high-performance liquid chromatography method.
authors.affiliation: Pharmacia Research and Development, 4901 Searle Parkway, Skokie, IL 60077, USA. kurt.r.sedo@pharmacia.com
authors.forename: K R
authors.initials: KR
authors.lastname: Sedo
authors.forename: C W
authors.initials: CW
authors.lastname: Demarest
authors.forename: Min
authors.initials: M
authors.lastname: Liu
authors.forename: Paul B
authors.initials: PB
authors.lastname: Wright
mesh_terms: D020374:Chromatography, Micellar Electrokinetic Capillary / Q000379:methods*; D004355:Drug Stability; D005240:Feasibility Studies; D006863:Hydrogen-Ion Concentration; D009994:Osmolar Concentration; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity