| 中文摘要 |
在本研究中開發出一個利用超臨界流體萃取以有效離析化妝品與藥物中常見的咪唑藥品（CT與KCZ）的方法。應用超臨界流體萃取藥用乳膏、藥錠與藥用洗髮精中的CT與KCZ後，再以高效液相層析儀測定，研究中所有的超臨界流體萃取都是以乙?為修飾劑，先經由10 min的靜態萃取，接著再進行15 min的動態萃取。在超臨界流體萃取之後，再以C18 管柱搭配二極體陣列偵測器，移動相為甲醇/去離子水/二已基胺/冰醋酸（80:20:0.3:0.2, v/v, pH 7.0），檢測波長為224 nm，流速為1.0 mL/min，測定CT與KCZ。本研究所開發出的方法應用在市售具有CT與KCZ的不同劑型藥物之例行定量而得到驗證。CT與KCZ的檢量線範圍分別為50~250 μg/mL，25~250 μg/mL；偵測極限分別為2.31 μg/mL與0.42 μg/mL；定量極限分別為7.70 μg/mL與1.40 μg/mL。以此方法應用在化妝品與藥物中的CT與KCZ，所得的實驗值與其商標上的教值有很好的一致性，五次重複測定得到良好的回收率，其值介於90.8~97.2%。" |
| 英文摘要 |
An effective method for isolating common imidazole drugs clotrimazole (CT) and ketoconazole (KCZ) from cosmetic and pharmaceutical products based on supercritical fluid extraction (SFE) was developed. Creams, tablets and cosmetic shampoos underwent supercritical carbon dioxide fluid extraction and CT and KCZ were determined by reverse-phase high performance liquid chromatography. All supercritical fluid extractions were performed with a 10-min static step, followed by a 15 min dynamic step using acetonitrile as the modifier. After extraction by SFE, KCZ and CT were separated on a C18 column using an isocratic mobile phase that consisted of methanol/water/diethylamine/glacial acetic acid (80:20:0.3:0.2, v/v, pH 7.0) at a flow rate of 1.0 mL/min. The eluates from column were monitored by absorbance at 224 nm using a diode array detector. This developed approach was validated by assaying commercial pharmaceuticals for the routine quantification of CT and KCZ in various formulations. The calibration curves for CT and KCZ were linear over the ranges of 50~250 μg/mL and 25~250 μg/mL, respectively. The detection limits of CT and KCZ were 2.31 μg/mL and 0.42 μg/mL, respectively, and the limits of quantitation were 7.70 μg/mL and 1.40 μg/mL, respectively. These drugs contents were found to be in good agreement with the label claim values. Satisfactory extraction recoveries ranging from 90.8% to 97.2% were obtained from five replicate extractions. |
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