药物分析中薄层色谱的方法认证

在药物分析中，针对所要求的性能参数，对一个薄层色谱程序的各个环节必须进行的认证方法和认可标准进行了讨论。建议当提出结果报告时，应附上关于对方法的认证参数和认证方法的说明。

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.