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[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):118-122.
　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):118-122.
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HPLC-MS/MS法測(cè)定人血漿中達(dá)比加群的濃度()
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《福建醫(yī)藥雜志》[ISSN:1002-2600/CN:35-1071/R]

卷:
40
期數(shù):
2018年06期
頁(yè)碼:
118-122
欄目:
基礎(chǔ)研究
出版日期:
2018-11-29

文章信息/Info

Title:
Determination of dabigatran in human plasma by HPLC-MS/MS
文章編號(hào):
1002-2600(2018)06-0118-06
作者:
陳 敏 陽(yáng)麗梅 羅冬梅 王長(zhǎng)連1
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;  YANG Limei;  LUO Dongmei;  WANG Changlian.
Department of Pharmacy,Fujian Provincial Hospital,Provincial Clinical Medical College of Fujian Medical University, Fuzhou, Fujian 350001, China
關(guān)鍵詞:
達(dá)比加群;  HPLC-MS/MS法;  血藥濃度
Keywords:
dabigatran;  HPLC-MS/MS;  plasma drug concentration
分類(lèi)號(hào):
R927.2
文獻(xiàn)標(biāo)志碼:
A
摘要:
目的 建立人血漿中達(dá)比加群(dabigatran)濃度的HPLC-MS/MS測(cè)定法,并對(duì)該方法進(jìn)行方法學(xué)驗(yàn)證。方法 血漿樣品采用甲醇直接沉淀,選擇鹽酸苯海拉明作為內(nèi)標(biāo)物。色譜柱采用InertSustainC18 HP(3.0 mm×100 mm,3 μm),流動(dòng)相采用甲醇-5%甲醇水溶液(含有10 mmol/L甲酸銨及0.1%甲酸)進(jìn)行梯度洗脫。結(jié)果 達(dá)比加群在10～500 ng/mL范圍內(nèi)呈良好的線(xiàn)性關(guān)系(r=0.999 5),定量下限是10 ng/mL; 保留時(shí)間是1.8 min,日內(nèi)、日間精密度(RSD)小于6.75%,準(zhǔn)確度在±4.12%以?xún)?nèi),基質(zhì)效應(yīng)在92.68%～94.37%以?xún)?nèi),提取回收率為90.95%～93.83%,血漿內(nèi)源性物質(zhì)對(duì)分析方法不干擾。結(jié)論 本實(shí)驗(yàn)建立了一種簡(jiǎn)單、高效的HPLC-MS/MS法檢測(cè)人血漿中的達(dá)比加群濃度。具有特異性強(qiáng)、專(zhuān)屬性高、操作簡(jiǎn)便、靈敏準(zhǔn)確等特點(diǎn)。
Abstract:
Objective To establish a sensitive and specific method for determination of dabigatran in human plasma by HPLC-MS/MS and validated the methods systematically. Methods The plasma samples were precipitated by methanol, and diphenhydramine hydrochloride was selected as the internal standard(IS). The analyte dabigatran and IS were separated on InertSustain C18 HP(3.0×100 mm, 3μm)with mobile phase of methanol-5% methanol aqueous solution(including 10 mmol/L ammonium formate and 0.1% formic acid)in gradient elution. Results The method exhibited a good linearity over the concentration range of 10～500 ng/mL(r=0.999 5). The quantification lower limit of dabigatran was 10 ng /mL, and the retention time was 1.8 min. The values on both the occasion(intra- and inter-day)were all within 6.75%, and the accuracy was within ±4.12%. The matrix effect was within 92.68%-94.37%, and the extraction recoveries were 90.95%-93.83%. There was absent of the interference of endogenous substances in plasma. Conclusion A simple and efficient HPLC-MS/MS method applied to the determination of dabigatran concentration has been established by this study, which is characterized by prominent specificity, simplicity, rapidity, high specificity, sensitivity as well as accuracy.

參考文獻(xiàn)/References:

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備注/Memo

備注/Memo:
基金項(xiàng)目:福建省自然科學(xué)基金資助項(xiàng)目(2017J01249) 1 福建醫(yī)科大學(xué)藥學(xué)院
更新日期/Last Update: 2018-11-29