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題 名 | Determination of 5-Fluorouracil in 5-Fluorouracil Injection and Human Serum by HPLC=高效液相層析法測定注射液及血清中5-Fluorouracil |
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作 者 | 祝玲; 申貴雋; 丁仕強; 華欣; | 書刊名 | Journal of Food and Drug Analysis |
卷 期 | 20:4 2012.12[民101.12] |
頁 次 | 頁947-950 |
分類號 | 414.81 |
關鍵詞 | 高效液相層析; 血清; 濃度; 5-FU; High performance liquid chromatography; Human serum; Drug concentration; |
語 文 | 英文(English) |
中文摘要 | 本研究開發一測定注射液及血清中5-Fluorouracil(5-FU)之高效液相層析法,層析管柱為Nova-park C18(3.9 × 150 mm, 4.6 μm),移動相為5 mmol/L磷酸二氫鉀(pH 6.0):甲醇(96:4, v/v),流速為1.0 mL/min,檢測波長為254 nm,血清經AgNO3(20%)和NaCl(20%)前處理,濃度範圍0.1-100 μg/mL(R^2 = 0.9999)時呈良好線性。5-FU注射液及血清中5-FU之最低檢出限量分別為0.10和0.85 μg/mL(S/N = 10),不同濃度的平均回收率分別為95.79 - 105.1%和90.2 - 108.8%。精密度相對標差RSD為0.4%,注射液和血清的穩定性和再現性分別小於1.3和2.1%(n = 5)。血清中之不純物不會產生干擾,以本方法測定5-FU注射液及血清中5-FU具簡單、快速、敏感且精確等優點。 |
英文摘要 | A high-performance liquid chromatography (HPLC) method was developed for the determination of 5-fluorouracil (5-FU) in 5-FU injection and human serum. A Nova-park C18 column (3.9 × 150 mm, 4.6 μm) and mobile phase consisting of 5 mmol/L KH2PO4 (pH 6.0) - methanol (96:4, v/v) at a flow rate of 1.0 mL/min were used for separation. The detection wavelength was set at 254 nm. The human serum was treated with AgNO3 (20%) and NaCl (20%). The method showed a good linear relationship in the range of 0.1 - 100 μg/mL (R^2 = 0.9999) with limits of quantification (LOQ) at 0.10 μg/mL and 0.85 μg/mL (S/N = 10) in 5-FU injection and human serum, respectively. The average recoveries of different concentrations in 5-FU injection and human serum were 95.79 - 105.1% and 90.2 - 108.8%, respectively. The relative standard deviation (RSD) of precision was 0.4%, and those of stability and repeatability were less than 1.3% and 2.1% (n = 5) in both samples, respectively. Impurities in the human serum did not interfere with the determination of 5-FU. The method is simple, rapid, sensitive and can accurately determine 5-FU in 5-FU injection and human serum. |
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