Bioanalytical liquid chromatographic method validation. A review of current practices and procedures

Validation of analytical methodologies is widely accepted as pivotal before they are put into routine use. Within the guidelines issued by Regulatory Authorities, there still exists scope for individual interpretation with respect to their conduct and acceptance criteria. The intention of this paper is to review the performances used and to provide practical approaches for determining selectivity, specificity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness of liquid chromatographic methods to support pharmacokinetic studies. A survey of recent literature on liquid chromatographic procedures used in the bioanalysis of anticancer drugs revealed that very variable standards were employed for validation.