RESUMO
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.
Assuntos
Preparações Farmacêuticas/análise , Potássio/análise , Calibragem , Química Farmacêutica/métodos , Cromatografia Líquida de Alta Pressão , Eletroforese/métodos , Concentração de Íons de Hidrogênio , Íons , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
Pharmaceutical analysis is undergoing a slow revolution as chemometric principles become increasingly incorporated. This paper reviews some of the more recent advances, with particular focus on spectrophotometry, chromatography and expert systems.