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机构地区:[1]苏州大学附属第二医院临床试验机构,江苏苏州215004
出 处:《中国临床药理学杂志》2015年第21期2137-2139,共3页The Chinese Journal of Clinical Pharmacology
摘 要:目的:建立高效液相色谱-质谱联用法测定血浆中拉莫三嗪浓度的方法。方法色谱柱WATERS XTerra RP18(4.6 mm ×100 mm,3.5μm),流动相为甲醇-10 mmoL· L-1醋酸铵(含0.05%甲酸)水溶液(50∶50),柱温为35℃,流速为0.8 mL· min-1,电喷雾离子源,正离子检测,检测专属性、标准曲线与定量下限、精密度与回收率、基质效应和稳定性。结果拉莫三嗪在5.0~1000.0μg· L-1线性关系良好(r=0.9988),批内和批间精密度的相对标准偏差(RSD)均小于15%,提取回收率96.5%~99.0%。结论本方法测定准确、灵敏、简便,可用于人血浆的拉莫三嗪浓度检测。Objective To develop a liquid chromatography-mass spec-trometry method for the determination of lamotrigine in human plasma. Methods WATERS XTerra RP18 (4.6 mm ×100 mm,3.5 μm) was employed to determine the plasma concentration of lamotrigine.Column temperature was 35 ℃.The mobile phase consisted of methanol and 10 mmol· L-1 ammonium acetate with 0.05% formic acid ( 50∶50 ) and flow rate was 0.8 mL· min -1 .A tandem mass spectrometry equipped with electrospray ionization source was used as the detector operated in positive ion mode for lamotrigine and benzoguanamine ( internal standard, IS) .The specificity, standard curve and lower limit of quantitation, precision and recovery rate and stability as well as the matrix effect were investigated.Results The standard curve of lamotrigine was linear over the concentration range of 5.0 -1000.0 μg· L-1 ( r =0.998 8 ) . Within-day RSD and between-day RSD were less than 15%,and the extraction recovery rate was all within 96.5%-99.0%.Conclusion The established analytical method is accurate, sensitive, convenient and suitable for the determination of lamotrigine in human plasma.
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