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目的建立简单、快速、灵敏的测定大鼠血浆中阿齐沙坦血药浓度的HPLC-荧光分析方法。方法色谱柱为Aglient Epilent plus C18(250 mm×4.6 mm,5μm),流动相为0.1%磷酸水溶液-甲醇(35∶65),激发波长为265 nm,吸收波长为378nm。结果血浆中内源性物质对待测物无干扰;线性范围为0.1~100μg/m L,R2=0.999;定量下限为0.1μg/m L;高中低浓度样品提取回收率在87.76%~95.65%,批内批间精密度RSD在0.86%~1.87%,相对误差RE均小于5%,符合相关生物样品检测标准。SD大鼠ig给予2.0 g/kg的阿齐沙坦酯钾后,阿齐沙坦在大鼠体内AUC0-t为(5451.94±297.96)μg/L·h,Cmax为(258.01±49.75)μg/m L。结论建立了专属性强、灵敏度高、重复性好的HPLC-荧光分析方法,可用于阿齐沙坦在大鼠血浆中血药浓度测定。
Objective To establish a simple, rapid and sensitive method for the determination of azilsartan in rat plasma by HPLC-fluorescence analysis. Methods The column was Aglient Epilent plus C18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 0.1% phosphoric acid solution (35:65) with an excitation wavelength of 265 nm and an absorption wavelength of 378 nm. Results The endogenous substances in the plasma showed no interference with the analytes. The linear range was 0.1-100 μg / mL and R2 = 0.999. The lower limit of quantitation was 0.1 μg / mL. The recoveries of high, intermediate and low concentration samples ranged from 87.76% to 95.65% Within the inter-batch precision RSD 0.86% ~ 1.87%, relative error RE less than 5%, in line with the relevant biological samples testing standards. After the rats were given 2.0g / kg azilsartan medoxomil, the AUC0-t of Azilsartan in rats was (5451.94 ± 297.96) μg / L · h and the Cmax was (258.01 ± 49.75) μg / m L. Conclusion A HPLC-fluorescence method with high specificity, high sensitivity and good reproducibility was established. It can be used to determine the plasma concentration of Azilsartan in rat plasma.