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目的:建立血浆中厄贝沙坦的高效液相色谱分析法。方法:血浆样品酸化后,叔丁基甲醚提取,再经HPLC-UV分析。色谱柱为LichrosperC18(250mm×4.5mm,5μm),柱温为35℃,流动相为甲醇-0.2%醋酸(67∶33),流速为1.0mL.min-1,检测波长为245nm。结果:血样中厄贝沙坦的线性范围为0.03～4mg·L-1,方法回收率为96.7%～102.4%,批内及批间RSD均小于10%,样品稳定性良好。将该法应用于测定大鼠体内厄贝沙坦的药时曲线,并计算药动学参数。结论:本法快速简便,准确灵敏,可用于厄贝沙坦的临床血药浓度监测及药动学研究。
Objective: To establish a high performance liquid chromatography method for the determination of irbesartan in plasma. Methods: Plasma samples were acidified, extracted with tert-butyl methyl ether and analyzed by HPLC-UV. The column was Lichrosper C18 (250 mm × 4.5 mm, 5 μm). The column temperature was 35 ℃, the mobile phase was methanol-0.2% acetic acid (67:33), the flow rate was 1.0 mL.min-1 and the detection wavelength was 245 nm. Results: The linear range of irbesartan was 0.03 ~ 4 mg · L-1 in blood samples. The recovery rate was 96.7% -102.4%. The RSDs within and between batches were less than 10%. The stability of samples was good. The method was applied to determine the pharmacokinetics parameters of irbesartan in rats. Conclusion: This method is rapid, simple, accurate and sensitive and can be used to monitor the clinical blood concentration and pharmacokinetics of irbesartan.