高效液相色谱法测定抑郁患者血浆中草酸艾司西酞普兰的浓度
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摘要
目的建立高效液相色谱法(HPLC)测定患者血浆中草酸艾司西酞普兰(草酸艾司西酞普兰)浓度。方法采用Ultimate3000型HPLC,UV(DAD-3000 RS),C_(18)(4.6 mm×250 mm,5μm)色谱柱,柱温:40℃。以甲醇-水-正丁胺-冰乙酸(56∶58∶1.5∶2)为流动相,艾司唑仑为内标,流速:0.8 ml/min,检测波长=238 nm。结果草酸艾司西酞普兰标准品峰与内标峰达到基线分离,分离度> 2.5,标准品及内标峰对应保留时间处无色谱峰干扰;其标准曲线为:Y=0.008 7 X+0.007 3(r=0.999 9),定量下限为5 ng/ml,萃取回收率86.54%～88.66%;方法回收率100.58%～103.2%;日内测定RSD为3.49%～9.27%,日间测定RSD为3.43%～8.37%,在10～160 ng/ml浓度范围内线性关系良好。结论该HPLC具有操作简便、血浆用量少、灵敏度高及检测限高等优点,适于草酸艾司西酞普兰血药浓度测定和药动学及生物利用度研究。
Objective To establish a HPLC method for the determination of escitalopram concentration in patients with depression plasma. Methods A HPLC method [Column: C_(18)(4.6 mm×250 mm,5μm); mobile phase: methanol-water-nbutylamine-glacial(56∶58∶1.5∶2); flow rate: 0.8 ml/min; Column temperature:40 ℃; Detection wavelength:238 nm] was used to determine escitalopram concentration. Results The escitalopram oxalate standard and internal standard peaks were separated from the baseline and the resolution was > 2.5.The blank serum had no peak interference at the retention time of the standard and internal standard peaks.The standard curve was:Y = 0.008 7 X + 0.007 3(r = 0.999 9),the lower limit of quantitation is 5 ng/ml,the linearity is well within the range of 10 to 160 ng/ml; the extraction recovery of Escitalopram were 86.54% ～ 88.66%;the methodological recovery were 100.58% ～ 103.2%;inter day RSD were 3.49% ～ 9.27% and within day RSD were 3.43% ～ 8.37%. Conclusions The advantages of this HPLC method are suitable for the monitoring of blood concentration of escitalopram oxalate; the serum concentration of escitalopram oxalate has good linear relationship in the range of 10 ～ 160 ng/ml.
Objective To establish a HPLC method for the determination of escitalopram concentration in patients with depression plasma. Methods A HPLC method [Column: C_(18)(4.6 mm×250 mm,5μm); mobile phase: methanol-water-nbutylamine-glacial(56∶58∶1.5∶2); flow rate: 0.8 ml/min; Column temperature:40 ℃; Detection wavelength:238 nm] was used to determine escitalopram concentration. Results The escitalopram oxalate standard and internal standard peaks were separated from the baseline and the resolution was > 2.5.The blank serum had no peak interference at the retention time of the standard and internal standard peaks.The standard curve was:Y = 0.008 7 X + 0.007 3(r = 0.999 9),the lower limit of quantitation is 5 ng/ml,the linearity is well within the range of 10 to 160 ng/ml; the extraction recovery of Escitalopram were 86.54% ～ 88.66%;the methodological recovery were 100.58% ～ 103.2%;inter day RSD were 3.49% ～ 9.27% and within day RSD were 3.43% ～ 8.37%. Conclusions The advantages of this HPLC method are suitable for the monitoring of blood concentration of escitalopram oxalate; the serum concentration of escitalopram oxalate has good linear relationship in the range of 10 ～ 160 ng/ml.
引文
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[6]Hiemke C,Baumann P,Bergman N,et al.AGNP consensus guidelines for therapeutic drug monitoring in psychiatry:update 2011[J].Pharmacopsychiatry,2011,44(6):195-235.
[2]汪开达.精神药理学[M].北京:人民卫生出版社,2007:420-421.
[3]司天梅,舒良.关于新抗抑郁药艾司西酞普兰[J].临床精神病学杂志,2007,17(1):68-69.
[4]陈新谦,金有豫,汤光.新编药物学[M].第17版,北京:人民卫生出版社,2011:282.
[5]中华医学会精神科分会.中国精神障碍分类与诊断标准.第3版(CCMD-3)[M].济南:山东科学技术出版社,2001:87-88.
[6]Hiemke C,Baumann P,Bergman N,et al.AGNP consensus guidelines for therapeutic drug monitoring in psychiatry:update 2011[J].Pharmacopsychiatry,2011,44(6):195-235.