Determination and clinical pharmacy application of quetiapine fumarate in human serum by RP-HPLC
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摘要: 目的 建立测定血清中富马酸喹硫平浓度的反相高效液相色谱(RP-HPLC)法并将其应用于临床。 方法 含药血清碱化后用乙醚萃取,应用RP-HPLC技术检测,色谱柱为Zorbax Eclipse XDB-C18,流动相为甲醇-水(70:30,含0.5%三乙胺,0.4%冰乙酸),流速为0.6 ml/min,检测波长为254 nm,柱温为35 ℃。对建立的方法应用于临床给药分析。 结果 血清中富马酸喹硫平与血清中杂质可完全分离,在50~1 000 ng/ml浓度范围内呈良好的线性关系(r=0.999 5),方法学回收率为98.2%~100.1%,萃取回收率为75.2%~84.6%,日间精密度RSD在0.8%~3.7%之间,日内精密度RSD在1.4%~5.1%之间,最低检测限(S/N=3)为2.1 ng/ml。将此方法应用于临床药学取得了较好的效果。 结论 该方法操作简便,结果准确,重现性好,灵敏度高,适用于富马酸喹硫平血药浓度监测,对指导临床合理用药,发现药物不合理联用等具有重要的意义。Abstract: Objective To establish a method for the determination of quetiapine fumarate in human serum by RP-HPLC and apply it into clinical. Methods Extracting with ethyl ether after serum-drug was alkalized, and then determined by RP-HPLC. The determination was performed on Zorbax Eclipse XDB-C18 column with mobile phase consisted of methanol-water (70:30, containing 0.5% triethylamine and 0.4% glacial acetic acid) at the flow rate of 0.6 ml/min. The detection wavelength was set at 254 nm, and the column temperature was 35 ℃. The method would be applied into analysis of clinical medication. Results Quetiapine fumarate and the impurities could be completely separated, and the linear range of quetiapine fumarate were 50-1 000 ng/ml(r=0.999 5).The recovery of the method was 98.2%-100.1% and the recovery of extracting was 75.2%-84.6%. RSD of intra-day was within 0.8%-3.7% and RSD of inter-day was within 1.4%-5.1%.The limit of quantitation for quetiapine fumarate was 2.1 ng/ml.This method had been applied into clinical pharmacy and achieved a good effects. Conclusions The method is simple, accurate, reproducible, and sensitive for determination of quetiapine fumarate in human serum. It has important significance on instructing the rational use of clinical medicine and discovering the unreasonable drug combination.
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Key words:
- RP-HPLC /
- quetiapine fumarate /
- serum concentration /
- clinical pharmacy
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[1] Marder SR.Management of treatment-resistant patients with schizophrenia[J]. Clin Psychiatry, 1996, 57(11): 26-30. [2] Khnlein O,Lutz R,Schmauss M,et al. Determining serum concentrations of the modern antipsychotic quetiapin:clinical relevance in therapeutic drug monitoring[J].Psychiatr Prax,2004,31( Suppl 1):175-177 [3] Gerlach M,Hünnerkopf R,Rothenhfer S, et al. Therapeutic drug monitoring of quetiapine in adolescents with psychotic disorders[J]. Pharmacopsychiatry,2007,40(2):72-76. [4] Guo RC, Fu CM. Relationship among serum concentrations, doses and clinilcal responses of quetiapine fumarate in patients with schizophrenia[J]. Chin J Clin Pharmacol Ther, 2003, 8(6): 627-630. [5] Mauri MC, Volonteri LS, Fiorentini A, et al.Two weeks' quetiapine treatment for schizophrenia, drug-induced psychosis and borderline personality disorder: a naturalistic study with drug plasma levels[J]. Expert Opin Pharmacother, 2007, 8(14): 2207-2213. [6] 李坤艳,李焕德.临床治疗剂量喹硫平体内代谢机制研究[J].中国药学杂志,2007,42(20):1564-1567. [7] 贾攀峰,张淑飞,王寿春,等.喹硫平对丙戊酸血清浓度的影响[J].中国药师,2009,12(4):534-535. [8] 林治光,翁毅仁,庄冬梅,等.RP-HPLC法测定人体中富马酸喹硫平血药浓度[J].四川精神卫生,2003,16(3):140-142. [9] Mandrioli R, Fanali S, Ferranti A, et al. HPLC analysis of the novel antipsychotic drug quetiapine in human plasma[J].J Pharm Biomed Anal,2002,30(4):969-977. [10] Lin SN, Chang Y, Moody DE, et al. A liquid chromatographic-electrospray-tandem mass spectrometric method for quantitation of quetiapine in human plasma and liver microsomes:application to study in vitro metabolism[J].J Anal Toxicol,2004,28(6):443-448. [11] 李坤艳,李焕德.HPLC-MS/ESI+测定人血浆中喹硫平及其代谢产物[J].中南药学,2006,4(2):88-91. [12] 金 鸣,卫婷婷,梁 曼,等.人血、尿中富马酸喹硫平的气相色谱分析[J].中国法医学杂志,2008,23(6):373-375. [13] DeVane CL,Nemeroff CB.Clinical pharmacokinetics of quetiapine:an atypical antipsychotic[J].Clin Pharmacokinet,2001,40(7):509-522. [14] Davis PC,Wong J,Gefvert O.Analysis and pharmacokineties of quetiapine and two metabolites in human plasma using reversed-phase HPLC with ultraviolet and electrochemical detection[J].J Pharm Biomed Ana1,1999,20(1-2):271-282. 期刊类型引用(2)
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