反相高效液相色谱法测定人血清中奥卡西平活性代谢产物的浓度
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摘要
目的建立反相高效液相色谱法测定人血清中奥卡西平(OXC)活性代谢产物MHD的浓度。方法收集血清样品经甲醇沉淀蛋白后,采用Inert Sustain C18(5μm,4.6×150 mm)色谱柱,流动相为甲醇-水(35:65),流速:0.8 mL/min,检测波长:210 nm,柱温:40℃,进样体积:20μL。结果血清中内源性物质对样品测定无干扰,MHD在4.8~38.4μg/mL线性关系良好,回归方程为:A=13968.3C-13730.7,r=0.9990。MHD的低、中、高3种浓度平均回收率均>95%,日内、间RSD均<3%(n=5)。结论反相高效液相色谱法简便、准确、灵敏度高,适用于人体内奥卡西平活性代谢产物MHD的血药浓度监测。
Objective To establish reversed-phase high performance liquid chromatography method for the determination of oxcarbazepine(OXC) active metabolite MHD concentration in human serum. Methods The serum samples were collected and the protein was precipitated by methanol, then Inert Sustain C18(5 μm, 4.6×150 mm) chromatography column was used, and the mobile phase was methanol-water(35:65), flow rate: 0.8 mL/min, detection wavelength: 210 nm,column temperature: 40℃, injection volume: 20 μL. Results The endogenous substances in serum did not interfere with the determination of the samples. The linearity of MHD was good from 4.8 to 38.4 μg/mL. The regression equation was:A =13968.3 C-13730.7, r =0.9990. The average recoveries of MHD at low, medium, and high concentrations were all >95%, and intra-and inter-day RSDs were <3%(n=5). Conclusion The reversed-phase high performance liquid chromatography method is simple, accurate and sensitive, which is suitable for monitoring the plasma concentration of MHD,an active metabolite of oxcarbazepine.
Objective To establish reversed-phase high performance liquid chromatography method for the determination of oxcarbazepine(OXC) active metabolite MHD concentration in human serum. Methods The serum samples were collected and the protein was precipitated by methanol, then Inert Sustain C18(5 μm, 4.6×150 mm) chromatography column was used, and the mobile phase was methanol-water(35:65), flow rate: 0.8 mL/min, detection wavelength: 210 nm,column temperature: 40℃, injection volume: 20 μL. Results The endogenous substances in serum did not interfere with the determination of the samples. The linearity of MHD was good from 4.8 to 38.4 μg/mL. The regression equation was:A =13968.3 C-13730.7, r =0.9990. The average recoveries of MHD at low, medium, and high concentrations were all >95%, and intra-and inter-day RSDs were <3%(n=5). Conclusion The reversed-phase high performance liquid chromatography method is simple, accurate and sensitive, which is suitable for monitoring the plasma concentration of MHD,an active metabolite of oxcarbazepine.
引文
[1]陈灏珠,林果为,王吉耀.实用内科学[M].第14版.北京:人民卫生出版社,2013:2763.
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[5]张宏久,周凡,闫小华,等.反相高效液相色谱法测定血清中奥卡西平的代谢产物单羟基衍生物[J].中南药学,2007,5(1):28-30.
[6]国家药典委员会.中华人民共和国药典临床用药须知:2010年版.化学药和生物制品卷[M].北京:中国医药科技出版社,2011.
[7]Antunes NJ,Wichert-Ana L,Coelho EB,et al.Analysis of unbound plasma concentration of oxcarbazepine and the 10-hydroxycarbazepine enantiomers by liquid chromatography with tandem mass spectrometry in healthy volunteers[J].J Pharm Biomed Anal,2018,149:442-447.
[8]杨杰.固相萃取-HPLC法测定人血清中10-羟基卡马西平的浓度[J].中国药房,2015,26(5):620-622.
[9]林奕沨,黄成坷,王哲,等.HPLC法同时检测人血浆中奥卡西平及其代谢产物浓度[J].中国临床药学杂志,2017,26(2):115-118.
[10]徐善森,张媞,周敬凯,等.高效液相色谱法测定人血浆中拉莫三嗪、奥卡西平及其代谢物浓度[J].中国临床药理学杂志,2015,31(12):1176-1179.
[11]谢宁,林志霞,杨红梅,等.HPLC法测定人血浆中奥卡西平及其活性代谢产物的浓度[J].中国药房,2015,26(11):1496-1499.
[12]陈艳平,鲁虹,史群志,等.高效液相色谱法测定人血浆中奥卡西平及其活性代谢产物的浓度[J].中南药学,2016,14(6):616-619.
[13]于超,王志强,张梅君,等.反相高效液相色谱法测定人血浆中奥卡西平的浓度[J].中国卫生检验杂志,2013,23(11):2495-2497.
[14]赵兴辉,陈俊珺,沈艳琳,等.临床药师参与拉莫三嗪及奥卡西平代谢物血药浓度监测及个体化给药分析[J].中国药物应用与监测,2016,13(5):274-276.
[15]林志燕,刘海涛,舒扬,等.217例次癫(癎)患儿血清奥卡西平代谢物浓度监测分析[J].医药导报,2013,32(1):12-14.
[16]冯健全,许俊羽,吴晔,等.RP-HPLC法测定人血浆和唾液中奥卡西平活性代谢物的浓度[J].中国临床药理学杂志,2013,29(4):299-301.
[2]Peng J,Hao LI,Song XW,et al.Oxcarbazepine vs.Carbamazepine monotherapy for partial epilepsy seizure:A Meta-analysis[J].China Pharmacy,2010,21(36):3420-3422.
[3]May TW,Korn-Merker E,Rambeck B.Clinical pharmacokinetics of oxcarbazepine[J].Clin Pharmacokinet,2003,42(12):1023-1042.
[4]Franceschi L,Furlanut M.A simple method to monitor plasma concentrations of oxcarbazepine,carbamazepine,their main metabolites and lamotrigine in epileptic patients[J].Pharmacological Research,2005,51(4):297-302.
[5]张宏久,周凡,闫小华,等.反相高效液相色谱法测定血清中奥卡西平的代谢产物单羟基衍生物[J].中南药学,2007,5(1):28-30.
[6]国家药典委员会.中华人民共和国药典临床用药须知:2010年版.化学药和生物制品卷[M].北京:中国医药科技出版社,2011.
[7]Antunes NJ,Wichert-Ana L,Coelho EB,et al.Analysis of unbound plasma concentration of oxcarbazepine and the 10-hydroxycarbazepine enantiomers by liquid chromatography with tandem mass spectrometry in healthy volunteers[J].J Pharm Biomed Anal,2018,149:442-447.
[8]杨杰.固相萃取-HPLC法测定人血清中10-羟基卡马西平的浓度[J].中国药房,2015,26(5):620-622.
[9]林奕沨,黄成坷,王哲,等.HPLC法同时检测人血浆中奥卡西平及其代谢产物浓度[J].中国临床药学杂志,2017,26(2):115-118.
[10]徐善森,张媞,周敬凯,等.高效液相色谱法测定人血浆中拉莫三嗪、奥卡西平及其代谢物浓度[J].中国临床药理学杂志,2015,31(12):1176-1179.
[11]谢宁,林志霞,杨红梅,等.HPLC法测定人血浆中奥卡西平及其活性代谢产物的浓度[J].中国药房,2015,26(11):1496-1499.
[12]陈艳平,鲁虹,史群志,等.高效液相色谱法测定人血浆中奥卡西平及其活性代谢产物的浓度[J].中南药学,2016,14(6):616-619.
[13]于超,王志强,张梅君,等.反相高效液相色谱法测定人血浆中奥卡西平的浓度[J].中国卫生检验杂志,2013,23(11):2495-2497.
[14]赵兴辉,陈俊珺,沈艳琳,等.临床药师参与拉莫三嗪及奥卡西平代谢物血药浓度监测及个体化给药分析[J].中国药物应用与监测,2016,13(5):274-276.
[15]林志燕,刘海涛,舒扬,等.217例次癫(癎)患儿血清奥卡西平代谢物浓度监测分析[J].医药导报,2013,32(1):12-14.
[16]冯健全,许俊羽,吴晔,等.RP-HPLC法测定人血浆和唾液中奥卡西平活性代谢物的浓度[J].中国临床药理学杂志,2013,29(4):299-301.