高效液相色谱法测定唑尼沙胺的血药浓度

Rapid determination of zonisamide in plasma by HPLC

目的:建立高效液相色谱法快速测定人血浆中唑尼沙胺的浓度。方法:色谱柱为DiamonsilC18柱(250mm×4.6mm,5μm),流动相为乙腈-10mmol·L-1磷酸二氢钠溶液(内含50mmol·L-1高氯酸,0.5%三乙胺,pH4.0)(34∶66),柱温室温流速1.0mL·min-1,检测波长238nm。结果:本测定方法的线性范围为1～80mg·L-1,r=0.9999。平均回收率为(98.0±3.2)%,日内RSD≤2.94%,日间RSD≤3.56%。唑尼沙胺的最低检测质量浓度为0.2mg·L-1。结论:本方法简单、快捷、灵敏、重现性好,适用于唑尼沙胺临床血药浓度监测及人体药动学研究。

OBJECTIVE To establish a rapid HPLC method for determination of zonisamide in plasma. METHODS A Diamonsil C18 column （5μm, 4. 6 mm× 250 mm） was adopted. Mobile phase was a mixture of CH3CN and 10 mmol·L^-1 NaHPO4 buffer （pH 4. 0, containing 50 mmol·L^-1 HClO4 and 0.5% （C2H5）3N） （34：66）. The flow rate was 1.0 mL·min^-1. The detection wavelength was at 238 nm. RESULTS The assay procedure was shown to produce linear calibration curves over the range of 1 to 80 mg·L^-1 of zonisamide in plasma （r = 0. 999 9）. Within the range, the recovery rate was （98. 0 ± 3.2） %, and the RSD within a day and between days was less than 2. 94% and 3.56%, respectively. The detection limit of zonisamide was 0. 2 mg·L^-1. CONCLUSION This method is found to be reproducible, convenient and sensitive for plasma concentration monitoring and clinical pharmacokinetics study of zonisamide.