H. Rosing et al., Bioanalytical liquid chromatographic method validation. A review of current practices and procedures, J LIQ CHR R, 23(3), 2000, pp. 329-354
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 re
spect 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 q
uantitation, linearity, range, accuracy, precision, recovery, stability, ru
ggedness, and robustness of liquid chromatographic methods to support pharm
acokinetic 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.