本文關(guān)鍵詞： 索拉菲尼 液質(zhì)聯(lián)用法 血藥濃度 藥代動力學(xué)　出處：《中國臨床藥理學(xué)雜志》2016年20期 　論文類型：期刊論文

【摘要】：目的建立人血漿中索拉菲尼濃度測定的HPLC-MS/MS方法。方法人血漿樣品用乙腈-沉淀蛋白后,色譜柱:Eclipse Plus C18(2.1 mm×100 mm,3.5μm),流動相:乙腈∶10 mmol·L~(-1)醋酸銨溶液(均含0.05%甲酸)=80∶20,流速:0.25 m L·min~(-1)。用電噴霧離子化源,正離子方式,多反應(yīng)監(jiān)測掃描方式進(jìn)行監(jiān)測。考察該方法的專屬性、標(biāo)準(zhǔn)曲線和定量下限、精密度與回收率、基質(zhì)效應(yīng)以及穩(wěn)定性。結(jié)果血漿中索拉菲尼的線性范圍為0.02~10.00μg·m L~(-1)(r=0.997 1),定量下限為0.02μg·m L~(-1);質(zhì)控樣品的準(zhǔn)確度在95.01%~104.86%;日內(nèi)、日間RSD均小于15%;提取回收率為82.08%~89.72%,無明顯基質(zhì)效應(yīng)。質(zhì)控樣品室溫放置8 h、處理后自動進(jìn)樣器4℃放置12 h,反復(fù)凍融3次,于-80℃環(huán)境中放置20 d后準(zhǔn)確度在91.78%~106.19%,RSD在4.31%~9.73%。結(jié)論本方法快速、靈敏、準(zhǔn)確,專屬性強,重復(fù)性好,適用于人血漿中索拉菲尼濃度的測定。
[Abstract]:Objective to establish a HPLC-MS/MS method for the determination of solafenil in human plasma. Methods Human plasma samples were treated with acetonitrile-precipitated protein. The chromatographic column was: eclipse Plus C182.1 mm 脳 100mm ~ (3. 5 渭 m). Mobile phase: acetonitrile: 10 mmol 路L ~ (-1) ammonium acetate solution (all containing 0.05% formic acid) 80: 20. The flow rate is 0.25 mL 路min ~ (-1). The electrospray ionization source, the positive ion mode and the multi-reaction monitoring and scanning method are monitored. The specificity, the standard curve and the quantitative limit of the method are investigated. Results the linear range of Solafenil in plasma was 0.02 渭 g 路mL ~ (-1) ~ (-1) 渭 g 路m ~ (-1). The lower limit of quantification is 0.02 渭 g 路mL ~ (-1); The accuracy of quality control samples was 95.01 and 104.86; During the day, RSD was less than 15. The recovery rate was 82.08% and 89.72%, and there was no obvious matrix effect. The quality control samples were stored at room temperature for 8 hours, and the automatic sampler was placed at 4 鈩，

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