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机构地区:[1]天津市儿童医院,天津300074 [2]天津市人民医院,天津300121
出 处:《中国药房》2013年第14期1272-1274,共3页China Pharmacy
基 金:天津市卫生局科技基金资助项目(No.2011KZ35)
摘 要:目的:建立测定人血清中左乙拉西坦浓度的方法。方法:血样经甲醇去蛋白处理后,采用高效液相色谱法进样测定。色谱柱为SunFire C18,流动相为50 mmol/L磷酸盐缓冲液(pH4.5)-乙腈(93.5∶6.5),流速为1.0ml/min,检测波长为205nm。结果:左乙拉西坦血药浓度在2.0~60.0mg/L范围内线性关系良好(r=0.9997),最低检测限为0.5mg/L;低、中、高3种质量浓度血样平均回收率为97.72%、97.67%、97.82%,日内RSD为2.74%、1.86%、1.63%,日间RSD为4.21%、1.88%、2.24%。18例患儿[给药量:左乙拉西坦片30~60mg(/kg·d)]血药浓度测得值为2.8~20.1mg/L,平均为(9.53±6.12)mg/L,个体差异大。结论:本方法精密、准确、特异性强、回收率高。OBJECTIVE: To establish a method for the determination of levetiracetam concentrations in human serum. METH- ODS: Serum samples were deproteinized with methanol. HPLC method was adopted. SunFire C18 column was used with mobile phase consisted of 50 mmol/L phosphate buffer (pH 4.5)-acetonitrile (93,5:6.5) at the flow rate of 1.0 ml/min. The detection wave- length was set at 205 nm. RESULTS: The linear range of levetiracetam was 2.0-60.0 mg/L(r=0.999 7), and the lowest limit of de- tection was 0.5 mg/L; at three concentrations, the average recoveries were 97.72%, 97.67% and 97.82%, respectively; RSD of in- tra-day were 2.74%, 1.84% and 1.62%; RSD of inter-day were 4.21%, 1.89 and 2.24% respectively. Serum concentrations of le- vetiracetam were 2.8-20.1 mg/L in 18 children [Levetiracetam tablets 30-60 mg/(kg·d)] with average concentration of (9.53 ± 6.12) mg/L, showing significant individual difference. CONCLUSIONS: The method is precise, accurate and specific with sound recov- ery.
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