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出 处:《中国新药与临床杂志》2011年第9期681-684,共4页Chinese Journal of New Drugs and Clinical Remedies
基 金:云南省自然科学基金资助项目(2000C0106M)
摘 要:目的建立反相高效液相色谱法测定人血浆中痂囊腔菌素A含量。方法血浆样品经处理后,采用RP-HPLC测定。色谱柱为Kromasil C18(250 mm×4.6 mm,5μm),流动相为乙腈∶水(70∶30,V/V),流速1 mL.min-1,柱温27℃,检测波长470 nm。结果痂囊腔菌素A在0.300~10.000 mg.L-1范围内线性关系良好(r=0.999 3),定量限为0.300 mg.L-1。低、中、高浓度(0.500,3.000,8.000 mg.L-1)的日内及日间RSD≤7.37%,平均提取回收率分别为(93.97±6.32)%,(91.71±5.79)%和(88.95±3.26)%。结论本法简便、快捷、灵敏、准确,可满足临床试验中痂囊腔菌素A药动学研究的需要。AIM To establish a reversed-phase HPLC method for the determination of elsinochrome A in human plasma. METHODS The chromatographic separation was performed on Kromasil Cls column (250 mm × 4.6 mm, 5 μm) with a mobile phase of acetonitrile-water (70 : 30, V/V) at a flow rate of 1.0 mL.min-1. The column temperature was 27 ℃ and the detection wavelength was 470 nm. RESULTS The linear concentration range for elsinochrome A was 0.300 - 10.000 mg.L-1 (r = 0.999 3). The limit of quantitation (LOQ) was 0.300 mg.L-1. The intra- and inter-assay coefficients of variation (CV%) for the three quality control samples (0.500, 3.000 and 8.000 mg.L-1) were ≤ 7.37% and the extraction recoveries were (93.97 ± 6.32)%, (91.71 ± 5.79) % and (88.95 ± 3.26) %, respectively. CONCLUSION This method is simple, rapid, sensitive and accurate, and is suitable for the pharmacokinetic study of elsinochrome A in clinical trials.
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