感冒藥糖漿有效成分定量－－實驗室間測試研究   全文下載

Quantitation of Active Ingredients in Cold Syrup-Collaborative Study

本實驗室間之測試研究是利用高效液相層析法測定感冒藥糖漿中有效成份的含量。十八家國內製劑藥廠的分析實驗室參加測試，分析的數據是利用排列分數及t值測試來評估測試的結果。由排列分數的測試了解，參與的實驗室都沒有明顯的系統性誤差。但是t值評估的結果指出有些實驗室做出來的數據不在95%的可信賴區內。依據實驗室內及實驗室間評估的結果，顯示本研究所提供的方法，適用於感冒藥糖漿中Acetaminophen、Caffeine、Guaifenesin的定量分析。

This collaborative study was performed with a high performance liguid chromatography method to determine the active ingredients content in the cold syrup. Eighteen local drug manufacturers' analytical laboratories participated in this study. The testing results were evaluated by using the ranking score and t-test techniques. The ranking score test indicated that none of the laboratories have any pronounced systematic errors, but results from the t-test evaluation indicated that some of the reported data were not within the 95% confidence level. According to the intralaboratory and interlaboratories studies, it has been shown that this analytical method is applicable to the determination of acetaminophen, caffeine and guaifenesin in cold syrup.