title: Validation of a capillary electrophoresis method for the determination of potassium counter-ion levels in an acidic drug salt.
abstract: This paper describes the first report of the validation of a capillary electrophoresis method for the quantitative determination of potassium levels in the potassium salt of an acidic drug. Validation criteria include precision, linearity, robustness and repeatability. The use of an internal standard enabled precision values of < 1% RSD to be obtained for peak area ratios. Careful control of capillary conditioning and temperature enabled migration time precisions of < 0.5% RSD. Results obtained by this method were in agreement with those generated by ion exchange chromatography and the theoretical potassium content of samples tested. Features of the method, compared to alternative analytical techniques, include simplicity, speed and accuracy. The method is now in routine use within our laboratories.
authors.affiliation: Glaxo Research and Development Ltd., Ware, Hertfordshire, UK.
authors.forename: K D
authors.initials: KD
authors.lastname: Altria
authors.forename: T
authors.initials: T
authors.lastname: Wood
authors.forename: R
authors.initials: R
authors.lastname: Kitscha
authors.forename: A
authors.initials: A
authors.lastname: Roberts-McIntosh
mesh_terms: D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002851:Chromatography, High Pressure Liquid; D004586:Electrophoresis / Q000379:methods; D006863:Hydrogen-Ion Concentration; D007477:Ions; D004364:Pharmaceutical Preparations / Q000032:analysis*; D011188:Potassium / Q000032:analysis*; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D007477:Ions; D004364:Pharmaceutical Preparations; D011188:Potassium