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高效液相色谱法测定人血浆中吡非尼酮的含量 被引量:3

Determination of pirfenidone in human plasma by HPLC
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摘要 目的建立高效液相色谱法测定人血浆中吡非尼酮的含量。方法色谱柱为Inspire-C18(150 mm×4.6 mm,5μm),流动相为甲醇-0.2%的磷酸溶液(59∶41,V/V),检测波长为310 nm,流速1 mL.min-1;血浆样品经10%高氯酸溶液沉淀蛋白后直接进样。结果吡非尼酮在0.2~25 mg.L-1范围内呈良好的线性关系(r=1.000)。方法回收率98.7%~106.7%,提取回收率大于73%,日内RSD小于2.6%、日间RSD小于5.9%。结论该方法灵敏,无杂质干扰,分析时间短,简便、准确,可用于临床吡非尼酮血药浓度的定量检测。 AIM To determine pirfenidone in human plasma by HPLC method. METHODS The plasma samples were denatured by 10% perchloric acid and the supernate were analyzed in a Inspire-Cts (150 mm x 4.6 mm, 5 μm) with methanol-0.2% phosphoric acid solution (59 : 41, V/V) as mobile phase. The flow rate was 1 mL "min-1 and detection wavelength was 310 nm. RESULTS The calibration curve of pirfenidone was linear within the range of 0.2 - 25 mg'L-1, r = 1.000. The method recovery was 98.7% - 106.7% and the extraction recoveries were more than 73%. RSD of inter-day and intra-day was less than 2.6% and 5.9%, respectively. CONCLUSION The method is sensitive with no endogenous interference, simple, accurate and can apply to the determination of clinical therapeutic concentration of pirfenidone.
出处 《中国新药与临床杂志》 CAS CSCD 北大核心 2013年第6期473-476,共4页 Chinese Journal of New Drugs and Clinical Remedies
关键词 吡非尼酮 色谱法 高压液相 血药浓度 药动学 pirfenidone chromatography, high pressure higuid plasma concentration pharmacokinetics
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参考文献6

  • 1AZUMA A, TAGUCHI Y, OGUA T, et al. Exploratory analysis of a phase III trial of pirfenidone identifies a subpopulation of patients with idiopathic pulmonary fibrosis as benefiting from treatment[J]. Respir Res, 2011, 12: 143.
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二级参考文献14

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