HPLC测定人血浆中醋氯芬酸药物浓度的研究
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摘要： 目的建立测定人血浆中醋氯芬酸浓度的高效液相色谱法。方法取血浆500μL酸化后用乙酸乙酯一步提取，40℃ 水浴氮气吹干，流动相复溶后进样测定。采用Hypersil C18柱 (250 mm×4.6 mm，5μm)；流动相为甲醇-0.1%冰醋酸(65:35，V/V)，流速1.2 mL/min；检测波长为276 nm，柱温为室温。结果醋氯芬酸的血药浓度在0.1～15.0μg/mL范围内线性关系良好，此方法的最低检测浓度为0.1μg/mL。血浆中低、中、高3种浓度的回收率分别为103.23%，104.33%，101.11%，精密度RSD日内为2.800%～6.841% ，日间为4.702%～8.161% 。结论该方法专属性强，重现性好，操作简便。适用于药动学研究和血药浓度监测。
关键词：醋氯芬酸；血浆；高效液相色谱
中图分类号：R927.2文献标识码：A文章编号：1672-979X(2007)10-0016-03
Determination of Aceclofenac in Human Plasma by HPLC
YIN Hong-yin, GAO Xi-bao*, ZHUO Jin-hua, FU Jun
(School of Public Health, Shandong University, Jinan 250012, China)
Abstract：Objective To establish a HPLC method for the determination of aceclofenac in human plasma.Methods Acidified samples of plasma (500μL) were extracted with 4 mL of ethyl acetate. The organic phase was evaporated to dryness by nitrogen at 40℃ water bath. The residue was redissolved in mobile phase and then was determined.Aceclofenac was detected on Hypersil Cl8 column (250 mm×4.6 mm, 5μm) at the wavelength of 276 nm and room temperature. The mobile phase was methanol-0.1% glacial acetic acid (65:35, V/V) and the flow rate was 1.2 mL/min. Results The linear range of calibration curve was 0.1～15.0μg/mL with the determination limit of 0.1μg/mL. The method recoveries of low，medium and high concentration were 103.23%, 104.33%, 101.11%, respectively. The within-day and between-day RSDs were 2.800%~6.841% and 4.702%~ 8.161%, respectively. Conclusion The developed methodwith good specificity and reproducibility is easy to operate, so it is suitable for the determination of aceclofenac in plasma.
Key words：aceclofenac; plasma; high performance liquid chromatography
醋氯芬酸(aceclofenac)是一种具有镇痛作用的非甾体类抗炎药物[1]，化学名为[邻-(2，6-二氯苯基)氨基]苯乙酰乙酸，l992年首先于西班牙上市，具有明显广泛的抗炎作用和强力的解热镇痛作用，其生物半衰期较双氯芬酸长，胃肠耐受性较双氯芬酸好，抗炎活性优于萘普生和保泰松[2]。醋氯芬酸的主要代谢产物为4-羟醋氯芬酸，双氯芬酸和4-羟双氯芬酸约为给药剂量的5%，清除半衰期为6.2 h[3]，由于其血浓度低，给检测工作带来困难。已有采用反向高效液相色谱法(RP-HPLC)测定血浆中醋氯芬酸浓度，以及HPLC测定醋氯芬酸片和胶囊中醋氯芬酸含量的的报道。但是，这些样品的处理方法复杂，稳定性不佳，且均需要内标物。本实验建立了一个以乙酸乙酯为提取剂，并在40 ℃水浴氮气吹干，浓缩后直接进样的新的简便且不需内标的方法 ......
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