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目的建立HPLC测定人血浆中伏立康唑血药浓度的方法,并应用于患者的个体化治疗。方法采用蛋白沉淀法对血样进行预处理后,进样检测人血浆中伏立康唑血药浓度。色谱条件:Gemini C18(4.6 mm×150mm,5μm)色谱柱,流动相:甲醇—水(40∶60);流速为1.0 ml/min,检测波长255 nm,柱温为30℃。结果伏立康唑在0.227~13.540μg/ml范围内线性良好(r=0.999),伏立康唑的绝对回收率为102.8%~113.6%,相对回收率为106.3%~111.4%,日内精密度和日间精密度RSD均小于5%。样本2℃~8℃保存的稳定性RSD均在3.00%以内。结论 HPLC测定方法简便、快速、准确,可用于伏立康唑的临床血药浓度监测。伏立康唑浓度个体间差异大,可预测性差,需对ICU和血液科严重侵袭性真菌病患者监测伏立康唑血药浓度。
OBJECTIVE To establish a HPLC method for the determination of voriconazole in human plasma and apply it to the individualized treatment of patients. Methods Pretreatment of blood samples by protein precipitation method was used to detect the plasma concentration of voriconazole in human plasma. Chromatographic conditions: Gemini C18 column (4.6 mm × 150 mm, 5 μm) with mobile phase of methanol-water (40:60), flow rate of 1.0 ml / min, detection wavelength of 255 nm and column temperature of 30 ℃. Results Voriconazole had good linearity (r = 0.999) in the range of 0.227 ~ 13.540μg / ml, the absolute recovery of voriconazole was 102.8% ~ 113.6%, and the relative recovery was 106.3% ~ 111.4%. Intravenous and intraday precision RSD Less than 5%. The stability RSDs of samples stored at 2 ℃ ~ 8 ℃ were all within 3.00%. Conclusion The HPLC method is simple, rapid and accurate and can be used for the clinical monitoring of voriconazole. Voriconazole concentrations vary widely among individuals and have poor predictability. Voriconazole plasma levels need to be monitored in ICU and patients with severe invasive hematologic disorders in hematology.