Critical topics in ensuring data quality in bioanalytical LC-MS method development

The use of LC-MS for bioanalysis of pharmaceuticals is entering its third decade and may be considered to be a mature technology. In many respects this is true, considering the advances made in such areas as instrument performance, electronics, software and automation of use. However, there remain instrumental and noninstrumental areas that require significant attention to ensure data quality. Increasing regulatory focus on analytical method performance and unaddressed method issues require the bioanalyst to understand those areas that most greatly impact data quality. This review will focus on instrumental and noninstrumental areas that can influence data quality, including reference standard and internal standard quality and physicochemical properties, matrix effects, stability in matrix, sample preparation, LC and MS.