title: Validated capillary electrophoresis method for the analysis of a range of acidic drugs and excipients.
abstract: A capillary electrophoresis (CE) method employing a high pH borate buffer has been validated to allow analysis of a wide range of acidic compounds including active drugs, pharmaceutical formulations, excipients, starting materials and intermediates. An internal database has been established to demonstrate the wide applicability of the method. The method has been extensively validated and is in routine use in a number of our laboratories worldwide. In particular, acceptable injection precision is obtained through the use of internal standards and the method robustness was evaluated using an experimental design. The method allows a number of cost and time saving benefits.
authors.affiliation: Pharmaceutical Development (Europe), GlaxoWellcome Research and Development, Ware, Herts, UK.
authors.forename: K D
authors.initials: KD
authors.lastname: Altria
authors.forename: S M
authors.initials: SM
authors.lastname: Bryant
authors.forename: T A
authors.initials: TA
authors.lastname: Hadgett
mesh_terms: D000143:Acids / Q000032:analysis*; D001881:Borates; D002021:Buffers; D004304:Dosage Forms; D004355:Drug Stability; D019075:Electrophoresis, Capillary; D005079:Excipients / Q000032:analysis*; D006863:Hydrogen-Ion Concentration; D004364:Pharmaceutical Preparations / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013056:Spectrophotometry, Ultraviolet
chemical_list: D000143:Acids; D001881:Borates; D002021:Buffers; D004304:Dosage Forms; D005079:Excipients; D004364:Pharmaceutical Preparations