液相層析法在中醫藥分析上的評估

Validation of Liquid Chromatographic Method in Herbal Medicine Analysis

在中醫藥或生物醫學的液相層析定量分析方法中，為了得到可靠的結果，各種處理過程必須考慮，這些過程包括取樣步驟、待測樣品處理步驟、液相層析移動相溶媒的組成、以及偵測器的選擇等。這些步驟必須通過嚴密的評估程序，這些評估程序包括以下幾個關鍵參數來決定：回收率、偵測強度、靈敏度、精確度、準確度、選擇度及安定性。為了更進一步改善液相層析方法在生物醫學的應用以及獲得滿意的結果，以上關鍵參數的定義都會在本綜論性文章來討論。

In order to obtain a reliable result of liquid chromatographic method in the application of herbal medicine or biomedical analysis, all the variable of the procedure method should be considered, including sampling procedure, sample preparative steps, mobile phase and detector selection. The procedure must go through a rigorous process of validation. The validation of liquid chromatographic method in biomedical application should include the following parameters: recovery, response function, sensitivity, precision, accuracy, selectivity and stability. To improve the chromatographic method in scientific application and obtain the satisfactory results, the definition of above parameters will be discussed in this review paper.