[Discussion of the validation of thin-layer chromatographic procedure in pharmaceutical analysis].
TLC has become a convenient, fast, robust, and cost efficient technique in pharmaceutical analysis because of its coherent features. The important analytical performance parameters are summarized, such as accuracy, precision, reproducibility, specificity, detection limit, quantitation limit, linearity and range, etc. The validation methods and the acceptance criteria are discussed for sample preparation, sample stability in solution and on plate, sample exposure time, robustness and quality of stationary and mobile phases, application of sample to plate, spot dimension and shape, temperature, humidity and chamber saturation, detection, and quantitation, etc. It is recommended that the definition of the validation parameters and the validation procedures for quantitative TLC should be described whenever the results are reported.
Lin
L
L
Dalian Institute of Chemical Physics, the Chinese Academy of Sciences, Dalian, 116012.
Zhang
J
J
D002855:Chromatography, Thin Layer / Q000379:methods* / Q000592:standards; D057230:Limit of Detection; D004364:Pharmaceutical Preparations / Q000032:analysis*
D004364:Pharmaceutical Preparations