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[1]陳 敏 高紅瑾 陽(yáng)麗梅.HPLC-MS/MS法測(cè)定人血漿中利伐沙班的濃度[J].福建醫(yī)藥雜志,2019,41(06):145-147.
　CHEN Min,GAO Hongjin,YANG Limei..Determination of rivaroxaban concentration in human plasma by HPLC-MS/MS[J].FUJIAN MEDICAL JOURNAL,2019,41(06):145-147.
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HPLC-MS/MS法測(cè)定人血漿中利伐沙班的濃度()
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《福建醫(yī)藥雜志》[ISSN:1002-2600/CN:35-1071/R]

卷:
41
期數(shù):
2019年06期
頁(yè)碼:
145-147
欄目:
基礎(chǔ)研究
出版日期:
2019-12-25

文章信息/Info

Title:
Determination of rivaroxaban concentration in human plasma by HPLC-MS/MS
文章編號(hào):
1002-2600(2019)06-0145-04
作者:
陳 敏 高紅瑾 陽(yáng)麗梅
福建醫(yī)科大學(xué)省立臨床醫(yī)學(xué)院 福建省立醫(yī)院藥學(xué)部(福州 350001)
Author(s):
CHEN Min; GAO Hongjin; YANG Limei.
Department of Pharmacy, Fujian Provincial Hospital, Provincial Clinical Medical College of Fujian Medical University, Fuzhou,Fujian 350001, China
關(guān)鍵詞:
利伐沙班;  HPLC-MS/MS法;  血藥濃度
Keywords:
rivaroxaban;  HPLC-MS/MS;  plasma drug concentration
分類號(hào):
R917
文獻(xiàn)標(biāo)志碼:
A
摘要:
目的 建立人血漿中利伐沙班(rivaroxaban)的高效液相色譜-串聯(lián)質(zhì)譜法(HPLC-MS/MS)法測(cè)定的方法,并對(duì)其進(jìn)行方法學(xué)驗(yàn)證。方法 血漿樣品采用乙腈直接沉淀,選擇鹽酸氨溴索作為內(nèi)標(biāo)物。采用菲羅門Kinetex 2.6u C18 100A(50×2.10 mm,1.8 μm)色譜柱,流動(dòng)相為乙腈:水(30:70)用甲酸調(diào)pH至3.0,流速0.3 mL/min,柱溫35 ℃,電噴霧離子源(ESI)正離子檢測(cè)方式,選擇多重反應(yīng)監(jiān)測(cè)模式進(jìn)行測(cè)定,用于定量的離子對(duì)分別為利伐沙班質(zhì)荷比(m/z)436.0/144.9、鹽酸氨溴索m/z 379.0/263.9。結(jié)果 利伐沙班在2.5～500 ng/mL范圍內(nèi)呈良好的線性關(guān)系(r=0.999 9),定量下限是2.5 ng/mL; 日內(nèi)、日間相對(duì)標(biāo)準(zhǔn)偏差(RSD)0.29%～2.38%,相對(duì)誤差(RE)―0.59%～0.90%,基質(zhì)效應(yīng)97.76%～100.41%,提取回收率為98.64%～102.84%。血漿樣品在室溫放置24 h、―20 ℃反復(fù)凍融3次以及―80 ℃冷凍30 d,不影響利伐沙班含量測(cè)定。結(jié)論 本研究建立的HPLC-MS/MS法測(cè)定利伐沙班血藥濃度,具有簡(jiǎn)便、快速、準(zhǔn)確,適用于臨床常規(guī)監(jiān)測(cè)及藥動(dòng)學(xué)研究等特點(diǎn)。
Abstract:
Objective To establish a HPLC-MS /MS method to determinate rivaroxaban concentration in human plasma, and the method was verified by methodology.Methods Plasma samples by acetonitrile precipitation were to be determined by using ambroxol hydrochloride as Internal Standard(IS).The chromatographic column was Kinetex 2.6u C18 100A(50×2.10 mm,1.8 μm), and the mobile phase using water(adjust pH to 3.0 with formic acid)-acetonitrile(70:30)with flow rate of 0.3 mL /min.The mass spectrometer was operated in positive electron spray lonization(ESI)and multiple response monitoring patterns, m/z 436.0/144.9 and m/z 379.0/263.9 were used for the measurement of rivaroxaban and ambroxol hydrochloride, respectively.Results Rivaroxaban was linear in the range of 2.5 to 500 ng/mL, and the quantification lower limit of rivaroxaban was 2.5 ng/mL.The intra-day and inter-day precisions(relative standard deviation, RSD)were 0.29% to 0.38%, the accuracy was between ―0.59% and 0.90%.The matrix effect was in the range of 97.76% to 100.41%, and the absolute recovery was in the range of 98.64% to 102.84%.The plasma samples were stable under conditions including placing at room temperature for 24 h, repeated freezing and thawing at ―20 ℃ for 3 times,and freezing at ―80 ℃ for 30 days.Conclusion The HPLC-MS/MS method established in our study is convenience, accurate and rapid for the determination of rivaroxaban in blood, which is applicable for the routine monitoring and PK study of rivaroxaban.

參考文獻(xiàn)/References:

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相似文獻(xiàn)/References:

[1]陳 敏 陽(yáng)麗梅 羅冬梅 王長(zhǎng)連.HPLC-MS/MS法測(cè)定人血漿中達(dá)比加群的濃度[J].福建醫(yī)藥雜志,2018,40(06):118.
　CHEN Min,YANG Limei,LUO Dongmei,et al.Determination of dabigatran in human plasma by HPLC-MS/MS[J].FUJIAN MEDICAL JOURNAL,2018,40(06):118.

更新日期/Last Update: 2019-12-25